Temporary cardiac pacing is often required for hospitalized cardiac patients, particularly for increasingly common transcatheter aortic valve replacement (TAVR) procedures. Startup Atacor Medical Inc. has raised a $25 million series B round to back its development of a novel extracardiac temporary pacing system. Intriguingly led by an undisclosed corporate partner, the financing is slated to get the company through a U.S. and European pivotal trial, as well as regulatory review in those regions. The San Clemente, Calif.-based startup also aims to continue developing interim and permanent iterations of its system. Read More
Saratoga, Calif.-based startup Mojo Vision Inc. has raised $51 million in a series B-1 financing led by existing investor New Enterprise Associates (NEA). The money will be used to advance development of the Mojo Lens, the company’s first-of-a-kind smart contact lens powered by augmented reality (AR) technology. Read More
The FDA’s 15-day deadline for responses to warning letters has long been a sore spot for device makers, who might argue that some of the more complex regulatory findings require more than 15 days to analyze and address. That same timeline was found in both the draft and final versions of the non-binding feedback guidance for device inspections despite industry’s pleas that such a tight deadline leads to rushed judgment and potentially inadequate responses by managers at the manufacturing site. Read More
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application. Read More
Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals. Read More
Artificial intelligence-focused Chronolife SAS, of Paris, has secured class IIa medical certification from the EU for its smart T-shirt, which has the new brand name Keesense. The reusable, washable T-shirt is designed for comfortable, round-the-clock use. It works by transmitting data to a paired smartphone app via Bluetooth. Read More
DUBLIN – Kurma Partners closed its third biotech fund, Kurma Biofund III, at €160 million (US$174 million), €10 million ahead of its initial target. The Paris-based fund will allocate the bulk of the capital to therapeutics firms, but it is also open to opportunistic investments in med tech, particularly in digital health applications and in biotech-med tech convergence, partner Peter Neubeck told BioWorld. Read More
Even as the world grapples with COVID-19, researchers and public health officials are trying to apply its lessons to future outbreaks. In our series “The next pandemic,” BioWorld explores the strategies and technologies that could improve the fight against future outbreaks, from robust surveillance to rapid vaccines. Read More
New hires and promotions in the med-tech industry, including: Axonics Modulation Technologies, Chan Zuckerberg Biohub, Elitech Group, Grail, Ra Medical Systems. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Hancock Jaffe, Istar Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Bioiq, Canon Medical Systems, Centene, Current Health, Dexcom, DFP Healthcare Acquisitions, ELT Sight, Intersystems, Labcorp, Masimo, Matrix Medical Network, Mayo Clinic, Medable, Medical Diagnostic Laboratories, Medplace, Mindray, Proteogenix, Pure Health, Quest Diagnostics, Seasun, Soc Telemed, Tmk Manufacturing, Trinity Health, Vander-Bend, Windtree. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno. Read More
Keeping you up to date on recent developments in orthopedics, including: Physio support in COVID-19 recovery; Co-delivery of IL-10 and NT-3 to enhance spinal cord injury repair; European countries face a costly 23% increase in fragility fractures by 2030. Read More
