Israeli venture capital fund, Shoni Health Ventures, launched a new fund focused on startups specializing in digital health and medical devices. Recognizing that innovative solutions with the potential to improve global health may go unrealized as health tech startups struggle to attract early-stage investors, the fund is focused on investing in companies at the pre-seed and seed-stage.
Two companies presented highlights of studies that demonstrated outstanding results for novel devices at last weekend’s American Diabetes Association’s (ADA) 83rd Scientific Sessions, while Embecta Corp. and Senseonics Holdings Inc. provided updates that position them well for long-term performance. Glyconics Ltd. revealed a fingernail scanning device that simplifies screening for diabetes and Fractyl Health Inc. showed that its Revita procedure reduced blood glucose levels and promoted weight loss.
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
Conformis Inc. has inked a definitive agreement to be acquired by Restor3d Inc., in a move that could potentially create a formidable presence in the personalized orthopedics space. Under the agreement, Restor3d will acquire all outstanding shares of Conformis common stock (NYSE:CFMS) at $2.27 per share in cash. The purchase price represents a roughly 96% premium to Conformis’ closing price on June 22, 2023.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kalos Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Double Black, LG Electronics, Luciole Medical, Pamgene, Rair Health, Shineco, Spiegelberg, Yangzhou Kangling.
The U.S. Office of Inspector General might not be the source of routine rules of the road for information blocking for electronic health records (EHRs), but the agency is tasked with some of the enforcement load. OIG just announced that $1 million fines for violations of information blocking rules will go into force in late August, a penalty that can accrue astonishingly quickly as it may apply per violation rather than per a series of related violations.
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