Hologic Inc. is tucking in yet another diagnostics manufacturer, this time with the acquisition of Mobidiag Oy for approximately $795 million. The privately held Finnish-French company develops and markets polymerase chain reaction (PCR)-based tests for acute care testing such as gastrointestinal and respiratory infections, antimicrobial resistance management and health care-associated infections. Read More
The FDA has its hands full with the impact of the mutations to the SARS-CoV-2 virus, but test developers can count on an ever-increasing base of data for those viruses thanks to a new contract taken by the CDC. The CDC indicated recently that its sequencing efforts and that of other organizations churned out nearly 14,000 sequences for the week of April 3, but Aegis Sciences Corp., of Nashville, Tenn., announced April 7 that it had undertaken an agreement to perform next-generation sequencing of samples from all 50 states and Puerto Rico, ensuring plenty of access to up-to-date information on those mutations. Read More
Bronchoscopic thermal vapor ablation (BTVA) destroyed lung tumors without significant safety issues, according to a study published in Respiration. The minimally invasive ablation procedure took 12 minutes using Uptake Medical Technology Inc.’s Intervapor system in the Vaporize study. Uptake is a subsidiary of San Jose, Calif.-based Broncus Medical Inc. Read More
A threat is currently hanging over the Swiss medical device industry, which is heavily reliant on trade with the EU. Upcoming changes to the CE marking regime will have the effect of making the mutual recognition agreement (MRA) obsolete. This currently allows Switzerland to enjoy unrestricted access to the medical device market in the 27 member states. Up until now, this bilateral agreement has regulated trade between Switzerland and the EU. Read More
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acornmed, Al Zahrawi Medical Supplies, Aumet Construction & Hospitals Management, Cardiovascular Systems, Carepics, Ceapro, Distribuidora Indexlab, EMD Serono, Emids, Exechealth, Ibex Medical Analytics, Invitae, Ischemaview, Magellan Rx Management, Merck, Mintcare, Moleculight, Nanomedix, Pelvalon, Philips, PRA Health Sciences, Quovantis Technologies, Rapidai, Renalytix AI, Sedeer Medical, Sightcall, Stago, Tradis Gat, Trapelo Health, Well Health Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Crown Aesthetics, Donisi, Eyeyon Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing. Read More
Keeping you up to date on recent developments in diagnostics, including: Method measures vital signs using smartphone camera; Improving purity of urine and plasma cfDNA. Read More
