PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld. Read More
As cyberattacks on U.S. hospitals continue to increase with health care’s growing reliance on technology, a new report from the U.S. Office of Inspector General (OIG) has flagged Medicare’s requirements for being silent on the cybersecurity of networked medical devices. The OIG’s study found hospitals are not required to identify networked device cybersecurity in their emergency preparedness risk assessments, and as a result, they don’t include this information “very often.” Read More
The U.S. Senate and the House of Representatives have reintroduced the Verifying Leading-edge IVCT Development (VALID) Act, a bill that would authorize the FDA to regulate lab-developed tests (LDT). The question of the agency’s statutory authority to regulate LDTs is part of a long-running debate, but the immediate question is whether Congress will see fit to deal with the question this year rather than wait until 2022, when the next device user fee will require legislative authorization. Read More
PERTH, Australia – Researchers at RMIT University and St. Vincent's Hospital in Melbourne have flipped traditional 3D printing to create more intricate biomedical structures, advancing new technologies for regrowing bones and tissue. Instead of making the bioscaffolds directly, the team 3D printed molds with intricately patterned cavities and then filled them with biocompatible materials, before dissolving the molds away. Read More
The U.S. House Appropriations subcommittee passed an appropriations bill for the FDA that would add $257 million to the agency’s budget authority for fiscal year 2022, an increase of 8% over the currently enacted level. The Alliance for a Stronger FDA said in a June 25 statement that it will work to ensure the Senate comes up with similar numbers, characterizing the push to fully fund the agency as “a multi-year marathon, not a sprint.” Read More
New hires and promotions in the med-tech industry, including: Akoya Biosciences, Boston Scientific, Cequr, Neux, Pixium Vision, Quantgene, Vifor Pharma. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BGI Genomics, Health Catalyst, Joimax, Lucida, Marco Ophthalmic, Natera, Nexcelom, Olleyes, Perkinelmer, Skylinedx, Twistle. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Peijia Medical. Read More
