Agilent Technologies Inc. will acquire Resolution Bioscience Inc. for $550 million in cash at closing and up to an additional $145 million based on performance milestones. The deal will expand Agilent’s cancer diagnostics offerings and its presence in next-generation sequencing (NGS) technology for the fast-growing precision medicine market. The acquisition is expected to close in April 2021. Read More
Several telehealth bills are in circulation on Capitol Hill, but U.S. federal government agencies have expressed concerns about the potential for fraud and abuse, and the impact on Medicare spending. Despite those concerns, two key members of the House Energy and Commerce (E&C) Committee, Reps. Frank Pallone (D-N.J.) and Anna Eshoo (D-Calif.), said during a March 2 hearing that they have misgivings about those cautionary views of telehealth, suggesting that any related legislation will aggressively expand Medicare coverage of telehealth. Read More
The FDA has granted de novo authorization to Fifth Eye Inc. for its Analytic for Hemodynamic Instability (AHI), a machine learning (ML)-based, real-time indicator of patient deterioration. Commercialization of the software device, which continuously monitors patients with an electrocardiogram (ECG) for signs of deterioration, got underway on March 1. Read More
HONG KONG – Looking to improve treatment outcomes for Alzheimer’s patients, Shanghai-based Luye Pharma Group has inked a deal to hand the Japanese rights for its leading treatment to Japan’s Towa Pharmaceutical Co. Ltd. Made through Luye’s subsidiary Luye Pharma Switzerland AG, the agreement gives Towa the exclusive rights for the development and commercialization of the Rivastigmine multi-day transdermal patch (Rivastigmine MD) in Japan. Read More
In Belgium, the National Institute for Health and Disability Insurance, INAMI, will reimburse costs for mobile health care applications as part of a care pathway. The move follows the green light given recently by the health care insurance committee. Online platforms, mobile apps and connected devices all have grown in popularity in recent months against the backdrop of the COVID-19 pandemic. Read More
New hires and promotions in the med-tech industry, including: Acutus Medical, Axogen, Deep 6 AI, Deepcell, Egenesis, Glaukos, Medx Health, Novan, Philips, Picnichealth, Pieriandx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Dariohealth, Medtronic, Neovasc, SPR Therapeutics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accufix Surgical, Anuncia, Conformis, Fifth Eye, Guardant Health, Masimo, Neurolief. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing. Read More
Keeping you up to date on recent developments in oncology, including: Imaging studies offer clarity on impact of combo therapy in metastatic breast cancer; Antidiarrheal drug fights AML; Peering past gastrointestinal mucosa to find tumors; Nanosac to the rescue for solid tumor therapy. Read More
