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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

April 25, 2023

View Archived Issues
Omnipod Go - Insulet

FDA greenlights Omnipod Go for type 2 diabetes

Insulet Corp. has taken the lead in the race to bring insulin delivery systems to individuals with type 2 diabetes with U.S. FDA clearance of its Omnipod Go device. The delivery system is adapted for use by adults who use once-a-day basal insulin. The company plans to roll out Go in 2024. Read More

Little support seen for AI as inventor at US PTO

The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being. Read More
Smart Reporting software

EIB loans Smart Reporting €15M to drive digitalization of health care

The €15 million (US$16.45 million) loan Smart Reporting GmbH recently received from the European Investment Bank (EIB) will take the company a “long way” as it looks to expand the use of its artificial intelligence (AI)-based medical documentation technology which “helps clinicians improve their workflow and patients to get better care,” co-CEO Peter Vanovertveld, told BioWorld. Read More
Cyclopharm’s Technegas

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29. Read More
Meio Medical - Titian

Meio hopes for expedited approval for its Titian robot for cardiac electrophysiology

Meio Medical Inc.’s Titian, a surgical robot for navigation in cardiac electrophysiology, has been included in a Green Pathway for approval of medical devices in China, meaning it could get to market faster. Inclusion in the Green Pathway gives the medical device priority for reviewing and shortens the average registration time. Currently, Meio Medical is running a trial of Titian in multiple hospitals in China. Read More

Appointments and advancements for April 25, 2023

New hires and promotions in the med-tech industry, including: Butterfly Network, C2N Diagnostics, Elucid, KCAS, Veris Health, Science 37, Thomas Scientific. Read More

Financings for April 25, 2023

Med-tech firms raising money in public or private financings, including: Cliatech, Establishment Labs, Neteera Technologies, PD Neurotechnology, Springbok Analytics. Read More

In the clinic for April 25, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Moleculight, Myocene. Read More

Other news to note for April 25, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autism Analytica, Avenda, Click, Concertai, Cryoport, Limber Prosthetics, Nevro, Pathai, Quadrant Biosciences, Siemens, Siemens Healthineers, Trinity Biotech. Read More

Regulatory actions for April 25, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carl Zeiss Meditec, Insulet, Proprio. Read More

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