Trump proposes deep cuts to Medicaid, NIH funding

Share

Capitol HillPresident Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention.

The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier this week that Medicaid cuts wouldn’t get through Congress.

“I think the tradition is presidents write budget proposals and that the Senate and the House substitute their own, and so I wouldn’t expect that would carry the day,” he told The Hill.

The potential $610 billion cut to Medicaid would add to the $839 billion cut proposed by the American Health Care Act that passed in the House earlier this month.

The proposal to slash Medicaid funding goes against Trump’s campaign promise to leave Medicaid, Medicare and Social Security funds untouched.

Among the more significant reductions proposed in Trump’s budget are an -19% cut to the National Cancer Institute and a -28% cut to spending on environmental health. The budget would also trim funding for the National Science Foundation by $776 million, or -11%.

According to the president’s proposal, the FDA would receive $1.89 billion in direct government funding. The 31% decrease would be offset by an increase of $1.3 billion in user fees.

Rep. Tom Cole (R-Okla.) said the proposed $5.8 billion cut to NIH funding “penny-wise and pound-foolish”, according to Stat. Cole is the chair of the House health appropriations subcommittee.

The proposal did not include any direct cuts to Medicare.

CDC director Dr. Tom Frieden took to Twitter to respond to the administration’s proposal, calling it an “assault on science.”

Also today, Rep. Tom Macarthur (R-NJ) resigned as co-chairman of the so-called Tuesday Group, a caucus of moderate House Republicans, citing divisions over efforts to repeal and replace former President Barack Obama’s healthcare law, according to a report from Politico. 

Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu

  • ‘Radiating Shoe Sales’

    By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]

  • Invetech announces senior management changes

    Invetech – provider of instrument development, custom automation and contract manufacturing – has announced refinements to its senior management structure as it continues to pursue growth in the diagnostics, connected health and cell therapy automation markets. Anthony Annibale has accepted the role of  global VP of sales, diagnostics and healthcare. Annibale is a proven product […]

  • Apple Watch detects atrial fibrillation using built-in technology

    The Apple Watch can automatically detect atrial fibrillation (AF) using its built-in heart rate sensor and artificial intelligence, according to a new study. The research used a deep neural network that was based on photoplethysmographic (PPG) sensors that are frequently found in smart watches. When paired with an artificial intelligence-based algorithm, Apple Watch’s heart rate […]

  • NAMSA announces partnership with Naglreiter

    Medical research organization NAMSA today announced a partnership with the Naglreiter medical device development organization, which focuses on medical device design, development and manufacturing. For nearly 50 years, NAMSA has focused on offering the most critical services required to accelerate time-to-market and reduce costs for medical device research clients across the world. Consistently recognized as a pioneer in […]

  • Resonetics adds applications development lab and nitinol processing to San Diego facility

    Resonetics has announced its plans to add a Lightspeed ADLTM application development lab to its manufacturing site in San Diego. The site will offer a variety of micro manufacturing tools to service medical device and diagnostics customers and will feature various laser wavelengths optimized for polymers, glass and metals. In addition, the San Diego facility […]

  • TransEnterix CEO: Robotic surgery has a big problem

    Todd Pope has been working in the surgical robotics space for over a decade. As the CEO of TransEnterix, which has developed Senhance surgical assistance device, Pope believes the surgical robotics market is about to explode. But before it can take off, Pope noted that players have to address a really big problem with robotic […]

  • Stratasys unveils multi-cell additive manufacturing platform

    Stratasys has launched its Continuous Build 3D Demonstrator multi-cell additive manufacturing platform for low-volume, continuous production. The Continuous Build 3D Demonstrator is a modular unit that has multiple 3D print cells working together through a central, cloud-based architecture. The platform is designed to create parts in a continuous manner with very little minor operator intervention. […]

  • Spectrum Plastics Group: Why the merger took place

    The M&A deal creating Spectrum Plastics Group is but the latest in a wave of consolidations taking place among medical device industry outsourcers. Mauricio Arellano, president of Spectrum’s medical division, thinks 2 trends are driving the consolidations: the need of OEMs to provide truly disruptive innovations to meet health providers needs for value-based care, and […]

  • FDA and NIH launch new clinical trial protocol writing tool

    By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

  • 5 officials running healthcare under Trump

    President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping […]

  • Gut microbiomes can predict non-alcoholic fatty liver disease

    There is a microbe in stool samples that can predict non-alcoholic fatty liver disease (NAFLD), according to researchers at the University of California San Diego School of Medicine. NAFLD occurs when there is a build up extra fat in liver cells that isn’t caused by alcohol, according to the American Liver Foundation. The liver has […]

  • Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo

  • ‘Radiating Shoe Sales’

    By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]

  • Invetech announces senior management changes

    Invetech – provider of instrument development, custom automation and contract manufacturing – has announced refinements to its senior management structure as it continues to pursue growth in the diagnostics, connected health and cell therapy automation markets. Anthony Annibale has accepted the role of  global VP of sales, diagnostics and healthcare. Annibale is a proven product […]

  • Apple Watch detects atrial fibrillation using built-in technology

    The Apple Watch can automatically detect atrial fibrillation (AF) using its built-in heart rate sensor and artificial intelligence, according to a new study. The research used a deep neural network that was based on photoplethysmographic (PPG) sensors that are frequently found in smart watches. When paired with an artificial intelligence-based algorithm, Apple Watch’s heart rate […]

  • NAMSA announces partnership with Naglreiter

    Medical research organization NAMSA today announced a partnership with the Naglreiter medical device development organization, which focuses on medical device design, development and manufacturing. For nearly 50 years, NAMSA has focused on offering the most critical services required to accelerate time-to-market and reduce costs for medical device research clients across the world. Consistently recognized as a pioneer in […]

  • Resonetics adds applications development lab and nitinol processing to San Diego facility

    Resonetics has announced its plans to add a Lightspeed ADLTM application development lab to its manufacturing site in San Diego. The site will offer a variety of micro manufacturing tools to service medical device and diagnostics customers and will feature various laser wavelengths optimized for polymers, glass and metals. In addition, the San Diego facility […]

  • TransEnterix CEO: Robotic surgery has a big problem

    Todd Pope has been working in the surgical robotics space for over a decade. As the CEO of TransEnterix, which has developed Senhance surgical assistance device, Pope believes the surgical robotics market is about to explode. But before it can take off, Pope noted that players have to address a really big problem with robotic […]

  • Stratasys unveils multi-cell additive manufacturing platform

    Stratasys has launched its Continuous Build 3D Demonstrator multi-cell additive manufacturing platform for low-volume, continuous production. The Continuous Build 3D Demonstrator is a modular unit that has multiple 3D print cells working together through a central, cloud-based architecture. The platform is designed to create parts in a continuous manner with very little minor operator intervention. […]

  • Spectrum Plastics Group: Why the merger took place

    The M&A deal creating Spectrum Plastics Group is but the latest in a wave of consolidations taking place among medical device industry outsourcers. Mauricio Arellano, president of Spectrum’s medical division, thinks 2 trends are driving the consolidations: the need of OEMs to provide truly disruptive innovations to meet health providers needs for value-based care, and […]

  • FDA and NIH launch new clinical trial protocol writing tool

    By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

  • 5 officials running healthcare under Trump

    President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping […]

  • Gut microbiomes can predict non-alcoholic fatty liver disease

    There is a microbe in stool samples that can predict non-alcoholic fatty liver disease (NAFLD), according to researchers at the University of California San Diego School of Medicine. NAFLD occurs when there is a build up extra fat in liver cells that isn’t caused by alcohol, according to the American Liver Foundation. The liver has […]

  • Symic Bio raises $30m for peripheral vein graft failure therapy

    Share

    Symic BioSymic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures.

    Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, SB-061.

    The San Francisco-based company also said yesterday that it plans to launch a Phase III trial of SB-030 in 2018, following a pre-investigational new drug meeting with the FDA. Supported by interim results from the Phase I/IIa Shield study, the regulatory watchdog recommended that the company move forward with a single Phase III registration study.

    Get the full story at our sister site, Drug Delivery Business News.

    FDA labels Philips Respironics V60 ventilator recall as Class I

    Share

    Philips Respironics

    The FDA today labeled a recall of Royal Philips (NYSE:PHGRespironics‘ V60 ventilators as Class I.

    Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

    The Respironics V60 non-invasive ventilator is designed to provide continuous or intermittent breathing support to pediatric patients weighing at least 44 lbs or adult patients, according to the recall notice.

    The company is recalling the device over issues with pins within the internal cable that connects the ventilator’s motor to the control board which can become loose due to vibrations. A loose pin may prevent data from being transferred between the motor and control board, according to the FDA release, which could cause the ventilator to shut down unexpectedly and sound an alarm.

    An unexpected stop in ventilation could cause serious adverse health consequences, including death, the FDA said.

    The recall affects 20,690 V60 non-invasive ventilator units in the US manufactured between April 2, 2009 and Sept. 15, 2015 and distributed between April 4, 2009 and Sept. 14, 2015.

    In March, Philips Respironics recalled a select number of its V60 respiratory ventilators with version 2.20 software over issues with the software causing the blower motor to stall and the unit to shut down, according to a recall notice released this week.

    The recall affected all V60 ventilators manufactured between Aug. 17, 2016 and Jan. 4, 2017 with v2.20 software, the company said, with the caveat that the recall may affect units manufactured prior to Aug. 2016 which have had v2.20 software added in the field.

    Soterix Medical wins FDA 510(k) for IontoDC

    Share

    Soterix Medical

    Soterix Medical said today it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs  into the body.

    The New York-based company said that the newly-cleared IontoDC device provides 10, 20, 30 or 40 minutes of direct current at intensities varying between 1 and 2 mA, and includes resistance meters and automatic ramp up and down.

    “This clearance represents a significant milestone for our organization as we can now offer the IontoDC system to the medical community in the U.S. The IontoDC was designed for ease-of-use including simple controls and clear status displays.” regulatory affairs VP Renato Moratore said in a prepared statement.

    “The FDA clearance of this system builds on the reputation of Soterix Medical in providing equipment engineered to the highest medical device standards. The IontoDC technology is proven to provide exceptionally reliable and consistent performance.” CTO Dr. Abhishek Datta said in a press release.

    Last September, Soterix Medical said it won Health Canada approval for and launched its PainX transcranial direct current stimulation technology designed for treating pain disorders in adults.

    The PainX tDCS system is a non-invasive, battery-powered device designed to deliver mild current to a specific section of the cerebral cortex to modulate reaction to painful experiences or control pain perception, Soterix said. The company touted the device as a “highly-promising therapy” that avoids systemic side effects associated with oral pain medications.

    Anika touts Phase III data for Cingal knee therapy

  • ‘Radiating Shoe Sales’

    By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]

  • Invetech announces senior management changes

    Invetech – provider of instrument development, custom automation and contract manufacturing – has announced refinements to its senior management structure as it continues to pursue growth in the diagnostics, connected health and cell therapy automation markets. Anthony Annibale has accepted the role of  global VP of sales, diagnostics and healthcare. Annibale is a proven product […]

  • Apple Watch detects atrial fibrillation using built-in technology

    The Apple Watch can automatically detect atrial fibrillation (AF) using its built-in heart rate sensor and artificial intelligence, according to a new study. The research used a deep neural network that was based on photoplethysmographic (PPG) sensors that are frequently found in smart watches. When paired with an artificial intelligence-based algorithm, Apple Watch’s heart rate […]

  • NAMSA announces partnership with Naglreiter

    Medical research organization NAMSA today announced a partnership with the Naglreiter medical device development organization, which focuses on medical device design, development and manufacturing. For nearly 50 years, NAMSA has focused on offering the most critical services required to accelerate time-to-market and reduce costs for medical device research clients across the world. Consistently recognized as a pioneer in […]

  • Resonetics adds applications development lab and nitinol processing to San Diego facility

    Resonetics has announced its plans to add a Lightspeed ADLTM application development lab to its manufacturing site in San Diego. The site will offer a variety of micro manufacturing tools to service medical device and diagnostics customers and will feature various laser wavelengths optimized for polymers, glass and metals. In addition, the San Diego facility […]

  • TransEnterix CEO: Robotic surgery has a big problem

    Todd Pope has been working in the surgical robotics space for over a decade. As the CEO of TransEnterix, which has developed Senhance surgical assistance device, Pope believes the surgical robotics market is about to explode. But before it can take off, Pope noted that players have to address a really big problem with robotic […]

  • Stratasys unveils multi-cell additive manufacturing platform

    Stratasys has launched its Continuous Build 3D Demonstrator multi-cell additive manufacturing platform for low-volume, continuous production. The Continuous Build 3D Demonstrator is a modular unit that has multiple 3D print cells working together through a central, cloud-based architecture. The platform is designed to create parts in a continuous manner with very little minor operator intervention. […]

  • Spectrum Plastics Group: Why the merger took place

    The M&A deal creating Spectrum Plastics Group is but the latest in a wave of consolidations taking place among medical device industry outsourcers. Mauricio Arellano, president of Spectrum’s medical division, thinks 2 trends are driving the consolidations: the need of OEMs to provide truly disruptive innovations to meet health providers needs for value-based care, and […]

  • FDA and NIH launch new clinical trial protocol writing tool

    By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

  • 5 officials running healthcare under Trump

    President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping […]

  • Gut microbiomes can predict non-alcoholic fatty liver disease

    There is a microbe in stool samples that can predict non-alcoholic fatty liver disease (NAFLD), according to researchers at the University of California San Diego School of Medicine. NAFLD occurs when there is a build up extra fat in liver cells that isn’t caused by alcohol, according to the American Liver Foundation. The liver has […]

  • Intersect ENT updates on Sinuva steroid-releasing sinus implant

    Share

    Intersect ENTIntersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018.

    The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for patients with recurrent ethmoid sinus obstruction. Traditionally, treatment for the condition includes high-dose oral steroids and repeat surgery.

    Get the full story at our sister site, Drug Delivery Business News.

    Medrobotics wins colorectal indication for Flex robot-assisted surgery system

    MedroboticsMedrobotics said today that it won 510(k) clearance from the FDA for a colorectal procedure indication for its Flex robot-assisted surgery platform.

    The Raynham, Mass.-based company won expanded CE Mark approval in the European Union last October for Flex for performing colorectal procedures. The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication won CE Mark approval back in March 2014). Medrobotics bills itself as the 1st robotics firm to offer minimally invasive and steerable robotic products for colorectal applications.

    “The human gastrointestinal system is full of twists and turns, and rigid surgical robots were not designed to operate in that environment. The Flex robotic system was. Two years ago Medrobotics started revolutionizing treatment in the head and neck in the U.S. We can now begin doing that in colorectal procedures,” CEO Samuel Straface said today in prepared remarks. “American hospitals, surgeons and patients will be able to enjoy the benefits of the world’s only flexible, surgical robotic platform. It will easily integrate into hospitals due to its mobility and short learning curve.”

    “The Flex robotic system offers the promise to treat select colorectal patients transanally with a more consistent and an easier approach because it overcomes the limits of straight surgical instrumentation,” added Dr. Alessio Pigazzi of the University of California, Irvine. “Medrobotics is ushering in the first of a new generation of shapeable and steerable robotic surgical systems that offer the potential to reduce the invasiveness of surgical procedures for more patients.”

    Medtrotics said it’s developing new applications for the Flex system, including general surgery, gynecology and urology, that have yet to win a green light from the FDA.

    In February the company confirmed a $20 million funding round 1st reported by MassDevice.com in January, saying it’s earmarked the proceeds for expanding into new areas including single-port general and gynecological procedures. The cash will also go toward developing the next iteration of the Medrobotics Flex “with more fully robotic instrument options,” the company said at the time.

    Medrobotics raised $25 million in November 2015.

    Crospon wins FDA 510(k) for next-gen Endoflip system

    Crospon

    Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy.

    The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based company said.

    “This clearance represents a significant milestone for our organization as we can now offer physicians an additional tool that can be used during endoscopy, along with other diagnostic methods, to evaluate patients with symptoms consistent with gastrointestinal motility disorders” CEO & founder John O’Dea said in a prepared statement.

    The system allows operating clinicians to investigate for conditions including achalasia, GEJ outflow obstruction and other major or minor peristalsis disorders during endoscopy, as well as the ability to capture and store Endoflip images in patient records.

    “The stand out benefit of this application, for both patients and caregivers, is that the Flip Topography assessment can be performed in less than five minutes during upper endoscopy on a sedated patient. In addition to significantly reducing discomfort, the patient may not have to wait for testing at a specialized center, thereby reducing their time to treatment. While not always a substitute for manometry, Endoflip 2.0 can reveal situations of non-obstructive dysphagia which may benefit from further evaluation from manometry,” O’Dea said in a press release.

    Crospon said it will begin shipping the Endoflip 2.0 systems in June.