PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
TORONTO – Health Gauge Inc. (HG) and AI-on-Call Inc. will soon deploy a digital remote patient monitoring solution for early prediction of sepsis at three seniors' facilities located in British Columbia. HG’s smartwatch and AI-driven cloud platform capture an array of vital signs data, including blood pressure, heart and respiratory rates, and will be supported by AI-on-Call software that alerts medical staff to early signs of sepsis and acute illness.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANP Technologies, Breathesuite, Koya Medical, Medtronic, Nanowear, Nonagen, Seaspine, Selux Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig Technologies, Globus Medical, Navitus Health Solutions, Parachute Health, Plexus, Speedx, Sword Health, Syngenis, Synthetic Genomics, Telacare Health Solutions, Ventec Life Systems, Viewmyid Health, Viridos.
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.
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.
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.
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.
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