Insulet Corp. went on a buying spree this week with the acquisition of the assets of Automated Glucose Control LLC (AGC) and Bigfoot Biomedical Inc.'s automated insulin delivery (AID) patents. The Bigfoot and AGC deals each rang in at $25 million. Read More
The Feb. 13-14 meeting of the U.S. Medicare Evidence Development and Coverage Advisory Committee (MedCAC) was the second step in an effort by CMS to overhaul the coverage with evidence development (CED) mechanism. While the meeting took place with the overhang of the issue of coverage for U.S. FDA-designated breakthrough devices, it seems there are changes coming to the CED program regardless of the breakthrough devices question, such as the imposition of CED study milestones that would presumably thwart the never-ending CED study per a vote held during the hearing. Read More
The U.S. FDA granted 510(k) clearance to Hyperfine Inc. for improved artificial intelligence (AI)-powered software for its Swoop portable magnetic resonance imaging (MRI) device. The company launched the new software this week. Read More
Facing a chronic dependency on imports for medical devices, particularly more advanced and high-end products, India is working on programs to ramp up investment in the sector and improve the availability of skilled human resources, but many say these efforts are not enough. Read More
In decrying high U.S. drug prices, lawmakers often cite statistics about the number of patients who forgo or ration their prescriptions because of the out-of-pocket cost. Those discussions overlook the role payer utilization management tactics, including prior authorization, may play in patients abandoning their treatment, be it a specific drug or an imaging service. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Docsun Biomedical, Future Now Biotech, Electrocore, Eyenovia, Formosa Pharmaceuticals, Guardant Health, Mainz Biomed, Marylebone Lab, Instituto de Microecologia, Masimo, Neotech, Novocure, Vizient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Qiagen. Read More
