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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 11, 2020

View Archived Issues
Psychology-disorders-heads

Click Therapeutics, Boehringer Ingelheim partner on digital therapeutic for schizophrenia

Click Therapeutics Inc. and Boehringer Ingelheim GmbH inked a deal valued at more than $500 million to collaborate on the development and commercialization of a prescription-based digital therapeutic for schizophrenia. The mobile application, currently called CT-155, uses cognitive and neurobehavioral techniques to reduce the symptoms of schizophrenia, such as cognitive deficits and impaired social functioning. Read More
PAD-artery-plaque.png

FDA gives nod to Avinger’s Ocelaris image-guided CTO crossing system

Avinger Inc. has received U.S. FDA clearance for a its Ocelaris next-generation, image-guided chronic total occlusion (CTO) crossing system for patients with peripheral artery disease (PAD). The catheter-based system, which will be sold under the brand name Tigereye, provides real-time imaging from within the vessel during a CTO-crossing procedure. It will be available on a limited basis beginning later this year. Read More
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Advamed: NTAP term of eligibility stuck at three years in absence of pandemic override

Don May, Advamed’s executive vice president for payment and health care policy, said on a Sept. 11 press briefing that any device that misses its first year of new technology add-on payment (NTAP) eligibility may not be able to recover that year unless CMS makes an exception for the pandemic, seemingly leaving the Boston Scientific Eluvia device with only two years of eligibility for its NTAP application. Read More
Test collection envelope

Visible Genomics offers genetic test for age-related macular degeneration

Visible Genomics has launched a set of noninvasive genetic tests aimed at assessing the overall risk of developing age-related macular degeneration (AMD) or progressing with the disease. AMD is a common condition that affects the part of the eye called the macula. It typically blurs the central vision used in tasks like reading and driving and develops around age 50. Read More
europe-uk-flag-map.png

Industry finally gets guidance on licensing regime for devices in the U.K.

LONDON – With just four months to go until Brexit is activated, the start of September finally saw the med-tech industry get official guidance on the licensing regime for medical devices in the U.K. once the Medicines and Healthcare Products Agency (MHRA) becomes the standalone regulator Jan. 1, 2021. Read More
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More than 300 cybersecurity incidents reported by French health care organizations for the past year

PARIS – For the past three years, French health care establishments, hospitals, radiotherapy centers and medical biology laboratories have had to report any security incidents affecting their IT systems. The French national agency for digital health care (ANS) has just released its latest annual report. Read More

Appointments and advancements for Sept. 11, 2020

New hires and promotions in the med-tech industry, including: Invitae, Novasignal, United Therapeutics. Read More

Financings for Sept. 11, 2020

Med-tech firms raising money in public or private financings, including: 10x Genomics, Acarix, Avricore Health, Natera, Quotient. Read More

Med-tech gainers and losers for Sept. 8-11, 2020

The top 10 med-tech stock gainers and losers for the week. Read More

Other news to note for Sept. 11, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alliancerx Walgreens Prime, Bruker, Canopy Biosciences, Clearside Medical, Collective Medical, Fio, Genetic Technologies, Intelelabs, Intersect ENT, Natera, NaviFUS, Nebraska Health Information Initiative, Noridian Healthcare Solutions, Relay Medical, Todos Medical, Veracyte, Xifin. Read More

Regulatory actions for Sept. 11, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardio-Phoenix. Read More

Regulatory front for Sept. 11, 2020

The latest global regulatory news, changes and updates affecting medical devices and technologies. Read More

BioWorld MedTech’s Neurology Extra for Sept. 11, 2020

Keeping you up to date on recent developments in neurology, including: New molecule restores lost connections in the spinal cord, brain of mice; Brain stimulation reduces dyslexia deficits; Nerivio wearable piloted for relief in patients with chronic migraine. Read More

BioWorld MedTech Patent Highlights: Week 36

BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette. Read More

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