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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

June 26, 2024

View Archived Issues
Dexcom G7 CGM

More support for glucose monitors in type 2 diabetes

Continuous glucose monitors continue to post positive results for managing diabetes in an ever-expanding population. Long a mainstay of disease management for those with type 1 diabetes, the devices have also proved themselves in treating type 2 diabetes that requires multiple daily injections of insulin. Read More
women-gyno-uterus-ovary

Femasys receives CE mark for four women’s health products

Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU. Read More
Australian money

Radiopharm raises AU$70M as it brings on new investor Lantheus

Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million. Read More
Regulatory icons

MDCG amenable to data from ‘similar’ devices for orphan medical devices

The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products. Read More
Judge's gavel with US flag

Sandbagging again a theme in patent case between Apple and Omni

Sometimes a court cites long-standing precedent in deciding how to handle a case, but the U.S. Court of Appeals for the Federal Circuit leveraged a decision it rendered only last year in deciding a patent case between Apple Inc., and Omni Medsci Inc. Read More

US FDA issues CRL for Abbvie’s Parkinson’s drug, ABBV-951

After receiving a complete response letter (CRL) in 2023 related to device issues, North Chicago-based Abbvie Inc. received another CRL for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in advanced Parkinson’s disease, this time for issues at a third-party manufacturer. Read More

Appointments and advancements for June 26, 2024

New hires and promotions in the med-tech industry, including: Medtronic, Swift Medical. Read More

Financings for June 26, 2024

Med-tech firms raising money in public or private financings, including: Uromems. Read More

In the clinic for June 26, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Neurolief. Read More

Other news to note for June 26, 2024

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Cranius, GE Healthcare, Ricoh, Stratasys, T2 Biosystems. Read More

Regulatory actions for June 26, 2024

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Tempus. Read More

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