FDA releases brain-computer interface draft guidance


The FDA today released draft guidance for brain-computer interface devices, an emerging novel technology that allows users direct control of devices.

Brain-computer interface devices, which are currently all experimental, allow direct control of devices and are often used to control limb prostheses. The experimental systems have the potential to significantly aid individuals with severe disabilities and increase their level of interaction with the environment, the FDA said.

The federal watchdog said it recently held a public workshop focused on BCI devices which defined them as “neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities.”

The FDA said that a result of the workshop was the initiation of the draft guidance, which will be open to public comment as it is finalized.

FDA head Dr. Scott Gottlieb said that the draft guidance is considered a “leap-frog” guidance intended to help bridge current technology with future innovations.

The newly released guidance provides proposed recommendations for developers on what non-clinical testing and clinics study design could be used for developing BCI devices for patients with paralysis or amputations, and includes detailed technical advice and study design recommendations.

The FDA said that the guidance proposes that non-clinical device testing can be used to demonstrate mitigation of potential risks prior to clinical testing.

“Proper design of clinical trials is essential to provide reasonable assurance of safety and effectiveness to support a regulatory submission to the FDA,” Gottlieb wrote in the release.

The FDA said that it has also developed the Emerging Sciences Working Group, a team of 15 experts charged with conducting long-range horizon scanning and reporting back on emerging issues and new scientific advances.

In late 2017, researchers at Battelle  touted that the 1st user of its experimental NeuroLife system, a BCI system designed to restore upper body mobility control to paralyzed patients through mental control, has shown improved control smoothness and accuracy with the system.

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Sen. Warner enlists healthcare industry help on cybersecurity


[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

U.S. Senator Mark Warner (D-Va.) is wrote a letter to several healthcare organizations yesterday, asking their help in improving cybersecurity in the industry.

A member of the Senate Finance Committee and chair of the Senate cybersecurity caucus, Warner pointed to apparent gaps in oversight, expressed concern about the impact of cyberattacks on the health care sector, and said he wants to help develop strategies that strengthen information security.

Ransomeware and other cyberattacks have stunned the healthcare industry. The 2017 WannaCry attack affected hospitals in the U.S. and U.K., including medical devices made by Bayer, Siemens and others, according to the Health Information Trust Alliance. A 2017 report by internet security software company Trend Micro found that more than 100,000 medical devices and systems were exposed directly to the public internet. The U.S. Department of Homeland Security issued an alert in 2018 indicating that several GE Healthcare imaging devices were vulnerable to cyberattack.

Healthcare hacking incidents accounted for 44% of all tracked data breaches in 2018,  the most of any type of breach, according to a report published in HIPAA Journal.  FDA published an updated draft of its cybersecurity premarket guidance for medical device makers in October 2018.

Warner’s office sent the letters to medtech trade group AdvaMed, the Healthcare Information and Management Systems Society, the American Hospital Association, and several other organizations.

“I would like to work with you and other industry stakeholders to develop a short and long term strategy for reducing cybersecurity vulnerabilities in the health care sector,” Warner said in the letter. “It is my hope that with thoughtful and carefully considered feedback we can develop a national strategy that improves the safety, resilience, and security of our health care industry.”





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Second Sight Medical closes $35m rights offering

Second Sight Medical

Second Sight Medical (NSDQ:EYES) said today that it closed a $34.6 million rights offering.

The Sylmar, Calif.-based company said that it received subscriptions for a total of 45.8 million units, with a final subscription price of 72.4¢ per unit.

Second Sight said that entities controlled by board chair Gregg Williams acquired a total of 41.4 million units for a total investment of approximately $30 million.

The company said that it plans to issue 45.8 million shares of common stock and 45.8 million warrants to purchase an additional shares of the company’s stock at $1.47 per share. Warrants are set to expire at 5:00 p.m. on March 14, 2024, and are exercisable immediately.

Second Sight said that it expects to distribute the shares and warrants today.

“We are grateful to our existing shareholders for their support. The proceeds from this offering will enable us to continue gathering safety and efficacy data to advance the development of our proprietary Orion cortical visual prosthesis, and seek regulatory approval and ultimately commercialize Argus 2s. This financing allows us to progress toward our goal of making the dream of sight a reality for blind individuals around the world by developing commercially successful products that provide useful artificial vision,” prez & CEO Will McGuire said in a prepared statement.

Last November, Second Sight said that the Centers for Medicare & Medicaid Services finalized the outpatient payment rate for its Argus II retinal prosthesis system for the coming year.

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Swiss heart valve dev Novostia raises $7m


Swiss cardiovascular device developer Novostia said today it raised $6.5 million (CHF 6.5 million) to support its novel heart valve device.

The Neuchâtel-based company said that the valve, which will be designed for use as both an aortic and mitral valve replacement, is designed from the company’s proprietary high-performance biocompatible polymer.

Novostia said that the design, as well as the materials that make up the valve, eliminate the need for lifelong anticoagulant medication use or future replacements as well as the elimination of clicking noises often associated with the valves.

“Our technology should significantly improve the quality of life of people bearing a heart valve prosthesis, especially kids and young patients, while reducing overall healthcare costs. We appreciate the trust and support of our investors and look forward to bringing this long-awaited innovation to the patients and the physicians,” CEO Geoffroy Lapeyre said in a press release.

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Dexcom beats The Street with Q4, FY18 results

 (NSDQ:DXCM) topped expectations on Wall Street this week with its fourth quarter and full-year financial results.

The San Diego, Calif.-based company posted a net loss of -$179.7 million, or -$2.03 per share, on sales of $338 million for the 3 months ended Dec. 31, for sales growth of 52.9% compared with the same period last year.

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

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Boston Scientific prices $4.3m senior notes offering

Boston Scientific

Boston Scientific (NYSE:BSX) yesterday priced a public offering of senior notes worth approximately $4.3 billion.

The Marlborough, Mass.-based company said that it plans to offer $850 million in 3.45% notes due 2024, $850 million in 3.75% notes due 2026, $850 million in 4% notes due 2029, $750 million in 4.55% notes due 2039 and $1 billion in 4.7% notes due 2049.

The company said that it plans to use funds from the round to fund a portion of its BTG (LON:BTG) acquisition, which it announced last November.

Funds will also be used to redeem outstanding notes, including 6% notes due January 2020 and 2.85% notes due May 2020, and to repay amounts outstanding from its $1 billion term loan facility set to mature in August 2019.

Boston Scientific said that it expects the offering to close on February 25.

Earlier this month, the U.S. Federal Trade Commission requested more information about the proposed $4 billion tie-up of BTG and Boston Scientific, but the companies said they still expect the merger to close on schedule in mid-2019.

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Abbott touts real-world data for FreeStyle Libre glucose monitor

Abbott's FreeStyle LibreAbbott (NYSE:ABT) presented real-world data this week showing that use of its FreeStyle Libre glucose monitoring system reduced prolonged hypoglycemia and helped users achieve better glucose control.

At the 12th Advanced Technologies & Treatments for Diabetes meeting in Berlin, the company showcased a real-world evidence data set that included roughly 500,000 FreeStyle Libre system users.

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

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Mylan launches generic sublingual film for opioid dependence

Mylan logo - updatedMylan (NSDQ:MYL) said today that it launched its buprenorphine and naloxone sublingual film as a generic of Indivior‘s (LON:INDV) Suboxone sublingual film.

The product is indicated for the treatment of opioid dependence. The therapy should be used alongside counseling and psychosocial support for people living with opioid dependence, according to Mylan.

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

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Propeller Health study suggests 84% of asthma inhaler use performed incorrectly

ResMed, Propeller Health

ResMed (NYSE:RMD) subsidiary Propeller Health today released results from a new study exploring real-world use of rescue or controller inhalers that indicated that the majority of users did not use their inhalers properly.

Results from the research were published in The Journal of Allergy and Clinical Immunology: In Practice, the Madison, Wisc.-based company said.

Read the whole story on our sister site, Drug Delivery Business News

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Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal

Mauna Kea, Cook Medical

Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement.

The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio with an emphasis on characterizing upper urinary tract urothelial cancer.

“Mauna Kea was understandably excited by the prospect of combining our innovative, confocal laser endomicroscopy technology with an established medical devices and supplies company with global expertise in sales, marketing and medical education in the urology market. Unfortunately, due to the lack of commercial activity to-date, we have decided to terminate the agreement,” Mauna Kea CEO Robert Gershon said in a prepared statement.

Mauna Kea said that while it is disappointed at the lack of commercial progress in the urology market, the company is “encouraged by the significant progress we have made in the areas of product development, clearance and clinical validation” of the Cellvizio tech in the urology market.

“Specifically, there have been 16 publications studying the use of confocal laser endomicroscopy in urology over the last three years. These publications detail the clinical studies observing more than 150 patients, at 10 hospitals and academic institutions around the world and include some of the most prominent thought leaders in urology. In addition to building our level of clinical validation for Cellvizio in the area of urology in recent years, we have also made progress in introducing 3 new FDA-cleared and CE-marked products for cystoscopy, ureteroscopy and prostatectomy including robotic-assisted laparoscopic surgery which we believe reflects a growing appreciation for our differentiated technology among urologists around the world. We look forward to sharing an update on our progress in each of our markets around the world during 2018, as well as our strategic growth priorities for 2019, during our year-end financial results call on March 20, 2019,” CEO Gershon said in a press release.

Cook Medical has not yet officially commented on the termination of the agreement.

In December 2017, Mauna Kea said that it won expanded FDA 510(k) clearance for its Cellvizio confocal laser endomicroscopy platform and its Confocal Miniprobe devices.

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