Medical Device

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

A pilot partnership between the FDA and Canada's Medical Devices Programme has been so successful the two agencies will talk this week about how to expand it.

A-Fem Medical has filed a patent application to the US Patent Office for its RapidSense technology. The technology provides information for a range of medical tests, including a home pregnancy test the company is developing.

Fifteen million "Beijing Wandong" A-shares, issued by Beijing Wandong Medical Equipment, have been publicly listed and transacted on the domestic securities market.

St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.

A-Fem Medical has filed a patent application to the US Patent Office for its RapidSense technology. The technology provides information for a range of medical tests, including a home pregnancy test the company is developing.

Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.

A pilot partnership between the FDA and Canada's Medical Devices Programme has been so successful the two agencies will talk this week about how to expand it.

When a large medtech company sets up a venture fund, it typically invests in technologies that are adjacent to its pre-existing portfolio. Intuitive Surgical’s approach is different.

A computer-assisted surgical navigation system for use during total hip replacement surgery has been developed by Carnegie Mellon University and Shadyside Hospital in the US.

EU medical device consultant Trevor Lewis takes note of the recent, if belated, progress towards the building of the post-MDR playing field for medical device companies in Europe, but calls political decision-makers and economic operators to account: getting it right is nothing short of a matter of life and death, he tells In Vivo.

Innogenetics has launched its INNO-LIA ANA test for detecting autoimmune rheumatological disease. Autoimmune disorders, in which the body mistakenly attacks itself, are responsible for a large number of rheumatological diseases. The Belgian company estimates that in Europe alone autoimmune diseases affect as many as three million people, mostly women.

Millenium Biologix is to develop and commercialise Allelix Biopharmaceuticals' bone cell stimulating factor for medical device and implant applications. Millenium, based in Kingston, Ontario, Canada, says that the agent will complement its synthetic bone implants, which are able to promote new bone formation and remodelling.

US company Biometric Imaging has elected a former group vice-president of Baxter International, Dale Smith, to its board of directors.

The sixth annual edition of In Vivo’s Rising Leaders features entrepreneurs, academics, lawyers, regulators and innovators from around the globe, representing the forefront of creativity in health care.

Richard Lowenthal, co-founder, and CEO of ARS Pharma, highlights the crucial unmet need for needle-free injections. Challenging issues posed by current epinephrine injectors, In Vivo questions the current and future progression of Neffy.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.