Precision medicine company My Next Health Inc. (MNH) has guaranteed a $150 million equity capital commitment from Global Emerging Market (GEM), a $3.4 billion Luxembourg-based private investment group. MNH was formed in May 2020 due to a merger between functional genomics company The DNA Company and digital therapeutics platform My Pain Sensei. The New York-based company is developing genomics-based health management applications that offer patients personalized genetic insights. Read More
Ernst and Young’s (EY) annual Pulse of the Industry report released today provided proof of med tech’s strong rebound from the disruption of the pandemic. Research and development investment soared, deal activity hit new highs, venture capital poured $9.1 billion into the sector, IPOs doubled, and more than 9 out of 10 of commercial leaders reported increased revenues. Read More
The issue of FDA regulation of lab-developed tests (LDTs) has been percolating for a number of years, but the Verifying Leading-edge IVCT development (VALID) Act of 2021 appears to offer the solution. Several stakeholders, including Jeff Allen, president and CEO of Friends of Cancer Research, are eager to see the reforms come through quickly, given the increasingly vital role that tests such as companion diagnostics play in the care of patients facing potentially deadly diseases. Read More
Broncus Holding Corp.’s shares tumbled more than 20% on its first trading day on Friday, Sept. 24, in Hong Kong. It raised HK$1.55 billion (US$199.1 million) at HK$18.70 a share, the top end of its target range. Nearly half of the proceeds will be used for the R&D and commercialization of its two core interventional pulmonology products: the Intervapor system and the RF Generator + RF Ablation Catheter (RF-II). Read More
LONDON – Industry groups, patients’ representatives and clinicians have launched the European Alliance for Cardiovascular Health (EACH) to lobby for a comprehensive EU policy to address the increasing burden of cardiovascular disease. Read More
The FDA posted an advisory for health care professionals regarding a “potential for differences” between men and women in connection with the use of left atrial appendage (LAA) closure devices. The agency said that differences in procedural outcomes as described in a new medical journal article included a procedure-associated death rate of 0.3% among women undergoing the procedure, triple the rate of 0.1% in men. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Zebra Medical. Read More
