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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Jan. 31, 2022

View Archived Issues
John Drakenberg Renander and Alyin Tüzel

Alex Therapeutics signs digital therapeutics deal with Pfizer

Stockholm-based Alex Therapeutics AB is joining forces with pharmaceutical company Pfizer Inc. to roll out digital therapies to patients in Germany. The partnership will utilize Alex Therapeutics' Alex DTx platform for nicotine addiction in Germany. The platform combines cognitive behavioral therapy (CBT) and acceptance and commitment therapy with artificial intelligence (AI) to create treatments for a wide range of psychiatric and somatic disorders. Read More
FDA website and logo

FDA combo products guidance offers more flexibility for cross-labeling

U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay. Read More
Illustration of liver, blood vial overlaid on woman's silhouette

Liquid biopsy comes to NASH as liver disease explodes

With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy. Read More

Australia hammers out new models to improve access to health innovations, streamline tech assessments

PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries. Read More
Screenshot of surgical video demonstrating Rsip Vision's virtual measurement technology

Rsip Vision presents intra-op virtual measurements for laparoscopic and robot-assisted surgeries

Israel and U.S.-based Rsip Vision Ltd. has released a new supporting technology for intraoperative video analysis. The company says its offering provides real-time and accurate anatomical measurements in surgical videos. This supports a variety of clinical use cases, such as bariatric surgery and small bowel resection. Read More
Calculator, 100 dollar bills

Congress presses FDA, industry on device user fee agreement

The quinquennial user fee process for medical devices has always proven controversial, but the FDA and industry have missed a Jan. 15 deadline for an agreement to be presented to Congress. Recently, several members of the House and Senate inked a letter to the FDA about the missed deadline, a signal that the agency’s aspirations for a $2.5 billion user fee deal are in jeopardy. Read More

Becerra asked to intervene in US agency turf war over Alzheimer’s drugs

While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war. Read More

Appointments and advancements for Jan. 31, 2022

New hires and promotions in the med-tech industry, including: Carespan Health. Read More

Financings for Jan. 31, 2022

Med-tech firms raising money in public or private financings, including: Mainz Biomed. Read More

In the clinic for Jan. 31, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artivion, Spatz. Read More

Other news to note for Jan. 31, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atos Medical, Bluejay Diagnostics, Carmat, Carespan, Coloplast, Glo-Med, Inspira, Leap Therapeutics, Leica, Quest, Walmart. Read More

Regulatory actions for Jan. 31, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applaud Medical, Orasure Technologies. Read More

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