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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 15, 2022

View Archived Issues
Hummingbird

FDA upgrades label for Preceptis tympanostomy device

The U.S. FDA granted Preceptis Inc. an expanded clearance for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube procedures. The device was previously cleared in children 6-24 months, but the new clearance allows in-office procedures in all children six months and older. The minimally invasive device is designed to create an incision so the ear tube can be delivered using a single pass down the ear canal, without the use of general anesthesia. Read More
Pheno

BD and Accelerate Diagnostics collaborate on rapid antibiotic resistance test

Becton, Dickinson and Co. and Accelerate Diagnostics Inc. joined forces to knock out sepsis and put patients on the path to recovery in hours, not days. Read More
EU flag and light bulb

The troubled roll out of the MDR is holding back med-tech in Europe

Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, released its latest survey. This study analyses the availability of medical devices in 2022 in light of the Medical Devices Regulation (MDR) being implemented. Read More

Rx price negotiations to become US law

As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price. Read More
FDA website and logo

Twin med-tech firms snare warning letters after FDA finds responses unpersuasive

It is one thing to watch a U.S. FDA inspection fail to meet with the agency’s expectations regarding compliance with the Quality System Regulation, but it’s another to have four opportunities to respond to the inspectional findings and still end up with a warning letter.  Read More
U.K. flag on stethoscope

NICE eyes endorsement of Kardiamobile for patients taking antipsychotics

The link between the use of antipsychotic medications and the risk of sudden cardiac arrest may not have yet earned universal recognition among cardiologists, but the U.K. National Institute of Health and Care Excellence (NICE) has seen enough to believe the hypothesis has some merit. The agency recently proposed that the Kardiamobile 6L device by Alivecor Inc., of Mountain View, Calif., be covered for patients taking antipsychotic medications, a policy which if adopted would reflect what NICE sees as an unmet need for a population at grave risk. Read More

Appointments and advancements for Aug. 15, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cleerly, Inspire Medical. Read More

Financings for Aug. 15, 2022

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

Other news to note for Aug. 15, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amsel Medical, Anixa, Mi Healthcare, Outset, Personalis, Probo. Read More

Regulatory actions for Aug. 15, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dyad Medical, Hydrix, Preceptis. Read More

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