Fabric Genomics Inc.’s Gem artificial intelligence algorithm plus whole genome and whole exome data detected more than 90% of disease-causing variants in infants with rare diseases, a study in Genome Medicine demonstrated. The full process from blood sample to shortlist of causative variants and likely diseases takes just a matter of hours and the time to interpret whole genomes is condensed to about 15 minutes. Read More
The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force. Read More
The Scottish government has signed a deal with digital therapeutics company Big Health Inc. to make a cognitive behavior therapy (CBT) platform for anxiety and insomnia available through the NHS. It makes Scotland the first country to provide a digital therapeutic for anxiety and insomnia nationally. Read More
The speed at which the med-tech industry is completing mergers and acquisitions in 2021 is something quite contrary to the typical slowdown seen when the financing window is open wide. But yet, a total of 477 M&As valued at $109.18 billion have closed in the first three quarters this year, more in volume and value than for each of the previous three years, and during what appears to be the second best year on record for financings. The sector has already raised $42 billion. On the other hand, the lack of disclosed terms continues to weigh heavy on deals, making them appear on paper to be significantly below recent years, down by about 73% in comparison with 2020’s first three quarters. Importantly, though, numbers of completed deals for every quarter and for the combined nine months are at their highest levels ever. Read More
Glaukos Corp., of San Clemente, Calif., has taken another step forward in obtaining global market access for its Istent device for glaucoma with a positive coverage recommendation in Canada. Health Quality Ontario (HQO) has recommended that taxpayer dollars be used to cover the device in conjunction with cataract surgery, although the endorsement is limited to patients with mild to moderate glaucoma that is not well controlled with pressure-lowering medications. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Global Healthcare Exchange, Explorer Surgical, Pillar Biosciences, Labcorp, Milestone Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Electrocore, Feops, Varian. Read More
