RFPi wins FDA nod for non-contact blood flow imaging tech

RFPi’s iCertainty shows images of blood flow and perfusion without contact with the patient.

FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said.

iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce procedural complications or repeat surgeries, reduce hospital costs, and objectively measure and help to improve clinical outcomes, the company said in a prepared statement.

Get the full story on our sister site, Medical Design & Outsourcing.

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Gottlieb calls 400 workers back from furlough for ‘key inspections’

FDA

Approximately 400 employees at the FDA are being called back to work amidst the partial U.S. government shutdown, most of which will engage in key inspections or support inspectors, according to a series of tweets from FDA Commissioner Dr. Scott Gottlieb posted yesterday.

Approximately 100 of those 400 recalled workers will focus on inspections of high risk medical device manufacturing facilities, with an additional approximately 90 individuals focused on high risk biological manufacturing facilities, Gottlieb said. An additional 70 employees will focus on high risk drug manufacturing facilities.

The largest group, approximately 150, will be focused on food inspections, Gottlieb tweeted.

The partial government shutdown, currently the longest in U.S. history, resulted in the furlough of approximately 40% of the FDA’s staff, about 7,000 of an approximately 17,000 employees.

Essential public health employees have remained at work, as well as activities covered through the agency’s user fee programs – though Gottlieb warned in a separate set of tweets that user funded programs do not have an endless runway to continue.

For medical device companies, those that have already submitted an application and paid their required fees will continue to see their applications reviewed, Gottlieb said in a series of tweets on Monday.

“However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review,” Gottlieb said in a series of tweets.

The Medical Device User Fee Amendments program has a runway of approximately two to three months, Gottlieb said earlier this month.

The agency’s Prescription Drug User Fee Act is the “most vulnerable program” during the shutdown and will run out of funding first, Gottlieb said. He added that the funds will cover the agency into February, “but how far into Feb is still very fluid.”

“We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now,” Gottlieb said in a tweet.

The Generic Drug User Fee Amendments program has approximately one to two months of funding left, Gottlieb said.

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IschemaView wins expanded FDA nod for Rapid neuroimager

IschemaView

Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy.

With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute stroke patients with known occlusions of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure.

IschemaView touted its Rapid system as the only imaging platform approved for selecting stroke patients for clot removal.

“This FDA clearance confirms Rapid as the de facto standard in neuroimaging, not only for the automated analysis of brain images derived from CT and MRI, but now for the diagnosis and treatment of stroke. The new clearance will particularly benefit smaller community hospitals and the patients they serve. Because Rapid enables stroke treatment decisions that are based on intuitive and easily interpretable real-time views of brain perfusion, physicians will quickly and easily be able to determine which patients can be treated locally and which require urgent transfer to thrombectomy centers — bolstering the capabilities of smaller hospitals and therefore improving patient care,” CEO Don Listwin said in a press release.

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Additive Ortho wins FDA nod for 3D-printed customized foot & ankle implants

Additive OrthopaedicsAdditive Orthopaedics said yesterday that it won FDA 510(k) clearance for its patient specific 3D-printed locking lattice plates.

The newly cleared devices from the Little Silver, N.J.-based company now have indications from the federal watchdog for the alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as those in the foot and ankle.

“There will always be a need for traditional off-the-shelf orthopedic devices, but in cases of implant revisions, limb salvage, and trauma, using printing to manufacture a patient specific device can potentially lead to a better outcome.  Although we are still in the early stages for 3D printed patient specific implants, it has been a terrific journey developing the market in foot and ankle orthopaedics,” prez Greg Kowalczyk said in a press release.

Additive Ortho said that its patient specific implants will be the cornerstone of its Game Plan integrated surgical planning system which it hopes to launch later this year.

Last May, Additive Orthopaedics said that it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments.

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Ortho dev Ossio wins FDA nod for bio-integrative bone pins

Ossio

Orthopedic device company Ossio said yesterday that it won FDA 510(k) clearance for its OssioFiber BonePin family of products.

The Woburn, Mass.-based company said that products in the OssioFiber BonePin family feature a proprietary bio-integrative material that it claims provides stability and secures bone fixation during healing with no permanent hardware left behind.

The company said its newly cleared OssioFiber BonePins feature a proprietary fixation material, composed of a natural mineral fiber matrix, that it says aims to be the “first credible replacement to permanent fixation implants.”

“Surgical procedures to treat forefoot conditions are increasing in frequency as the population ages. While these procedures are considered to be effective, they can be associated with secondary implant removal surgeries due to mechanical failure, irritation and pain. Ossiofiber has the potential to be a true game-changer, with pre-clinical studies demonstrating its mechanical strength and bio-integrative nature,” Bob Baravarian of the UCLA School of Medicine and University Foot and Ankle Institute said in a prepared statement.

“An implant that maintains its strength through the known healing timeline, and is then completely integrated into the surrounding anatomy with no adverse inflammation is a real breakthrough for surgeons and the patients we treat,” Dr. Stuart Miller of MedStar Union Memorial Hospital and Johns Hopkins University School of Medicine said in a prepared release.

Ossio said it plans to commercially launch the OssioFiber BonePin family of devices during the second quarter of this year.

“Today’s FDA clearance of the Ossiofiber Bone Pin Family marks a significant milestone for our company, as we bring a new category of orthopedic fixation to the U.S. market. We look forward to partnering with surgeons throughout the United States to integrate the Ossiofiber platform into their surgical treatment options, ultimately changing the current standard-of-care in orthopedic fixation by encouraging natural bone healing that avoids unnecessary hardware removal surgeries and improves the overall healthcare economics of orthopedics. This regulatory achievement supports our overall mission to transform the patient experience,” CEO Brian Verrier said in a press release.

The company added that it has launched a multi-center clinical trial assessing the safety and performance of its OssioFiber hammertoe fixation implant, having already and enrolled and treated the first patient. Ossio said that results from the trial will support its CE Mark application for the device, which it expects to file next year.

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TransEnterix wins FDA clearance for Senhance Ultrasonic

TransEnterix-logoTransEnterix (NYSE:TRXC) said today that it won 510(k) clearance from the FDA for its Senhance Ultrasonic instrument system, designed to operate with its Senhance robot-assisted surgery device.

Senhance Ultrasonic instruments are designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury to surrounding structures, Research Triangle Park, N.C.-based TransEnterix said. The instrument set is now on the market in the U.S. and all countries that recognize the CE Mark, which the company won for Senhance Ultrasonic last October. The U.S. clearance for Senhance covers laparoscopic colorectal, gynecological, inguinal hernia and cholecystectomy procedures, TransEnterix said.

“Advanced energy devices are used within a high percentage of cases across a wide range of procedures, which make them a critical tool for laparoscopic surgeons,” president & CEO Todd Pope said in prepared remarks. “We believe the addition of the Senhance Ultrasonic system is significant and broadens the attractiveness of the Senhance platform and digital laparoscopy for surgeons in the U.S.”

“The addition of ultrasonic technology is a significant expansion of the Senhance system capability preferred by many surgeons during complex procedures,” added Dr. Steven McCarus of the Florida Hospital Celebration Health. “Combining advanced energy tools with the precision, control, haptics and ergonomics of the Senhance digital interface may allow many surgeons to confidently use this technology across the broadest range of pathology and patients.”

Senhance is the only market-cleared competitor for Intuitive Surgical (NSDQ:ISRG) and its da Vinci line of surgical robotics systems, which first won FDA approval in 2000. TransEnterix touts Senhance as the only platform with haptic force feedback, reusable instruments and 3mm instruments.

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5 top stories that mattered for medtech in 2018

medtech medical devices 2018

[Image by managing editor Chris Newmarker]

The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U.

It’s worth noting, though, that many things have been going right for medtech.

More than half of the roughly 100 largest medical device companies in the world saw their stock prices increase during 2018 – not a bad record considering the slumping Dow Jones Industrial Average and S&P 500.

Medical device companies spending a large amount on R&D compared to revenue – including Dexcom, Abiomed, Atricure, Edwards Lifesciences and Insulet – saw their stock prices skyrocket as they marketed innovative devices in fields including diabetes management and cardiology.

Artificial intelligence is playing a larger role in medtech innovation, medical device companies are increasingly forging partnerships with high tech companies, and there’s even a chance that the device industry might help combat the opioid epidemic.

Here are five trends that mattered for medtech in 2018 – and are bound to influence the future of the industry this year.

Next>>

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FDA adds back some workers during partial government shutdown

FDA-logo-newThe FDA has resumed several health and safety activities that had been halted by the partial government shutdown, now in its 24th day.

In a series of tweets on Sunday, FDA Commissioner Scott Gottlieb, M.D. listed the tasks that the agency has added to “excepted, unpaid work.”

“It is not business as usual at FDA. Many key functions aren’t getting done,” Gottlieb tweeted. “But we’re focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission-critical functions.”

Get the full story on our sister site, Medical Design & Outsourcing.

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Amneal wins FDA nod for generic rivastigmine transdermal patch

Amneal Pharmaceuticals logoAmneal Pharmaceuticals (NYSE:AMRX) said today that it won FDA approval for a generic rivastigmine transdermal patch.

The drug, which is sold under the brand name Exelon, is an acetylcholinesterase inhibitor that is commonly used to treat mild to moderate Alzheimer’s disease and Parkinson’s disease.

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

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Abbott wins FDA approval for Amplatzer Piccolo occluder for neonates

AbbottThe FDA granted pre-market approval for the Amplatzer Piccolo occluder made by Abbott (NYSE:ABT) to treat a congenital heart defect in neonatal infants as small as two pounds, the company said today.

The Chicago-area healthcare giant said Amplatzer Piccolo is a transcatheter, self-expanding, wire mesh device that’s inserted via the aortic or pulmonary artery to close a hole in the heart known as patent ductus arteriosus.

“Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts,” structural heart VP Michael Dale said in prepared remarks. “Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve.”

“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” added Dr. Evan Zahn, of the Cedars-Sinai’s Smidt Heart Institute Los Angeles, who was principal investigator for the Amplatzer Piccolo pivotal trial.

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