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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Jan. 18, 2023

View Archived Issues
sepsis-bacteria-blood.png

Cytovale gets FDA nod for 10-minute sepsis test

Cytovale Inc. received U.S. FDA 510(k) clearance for its Intellisep sepsis test, which can aid in the diagnosis of the often fatal condition within 10 minutes. Cytovale is one of several companies and collaborations that aim to sharply reduce the time to diagnosis and the mortality rate for sepsis by providing quicker, more informative test results and standardizing protocols.

Read More
Navitor - Abbott

Abbott wins FDA nod for next-gen Navitor valve

The U.S. FDA has given the green light to Abbott Laboratories Inc. for its Navitor next-generation transcatheter aortic valve implantation (TAVI) system for the treatment of patients with aortic valve stenosis who are at increased risk of open-heart surgery. Abbott won European approval of Navitor in May 2021. Read More
Lisa implant - Backbone SAS

Companion Spine acquires Backbone, expanding its degenerative disc product portfolio

Companion Spine SAS has acquired Backbone SAS, a company that develops implantable functional motion restoration devices for treating spinal disorders. The inclusion of Backbone's flagship medical device, Lisa – a lumbar implant for stiffness augmentation – completes the Companion Spine portfolio. Read More

Resolute FDA churning out de novo announcements in effort to catch up

The new year always brings with it a series of New Year’s resolutions, and the U.S. FDA has apparently resolved to catch up on its backlog of de novo notifications. The earlier of the two de novo regulatory announcements is for a digital product by Minneapolis-based Nightware Inc., and its namesake kit for reduction of sleep disturbances, a regulation that arrives more than two years after the product was granted market access. Read More
European Commision headquarters

New EU stockpile to prepare for CBRN events

The European Commission is spending €242 million (US$261 million) to create the first rescEU strategic reserve of chemical, biological, radiological and nuclear (CBRN) medical countermeasures. Read More
deal-merger-sign.png

US FTC proposes making noncompetes a thing of the past

If the U.S. FTC has its way in banning all noncompete employment agreements, a lot of biopharma and med-tech companies are going to have to rethink how they protect sensitive information and business strategies. Read More

Appointments and advancements for Jan. 18, 2023

New hires and promotions in the med-tech industry, including: Advamed, Aposhealth, Cxl Ophthalmics, Turbett Surgical. Read More

Financings for Jan. 18, 2023

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

In the clinic for Jan. 18, 2023

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

Other news to note for Jan. 18, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acufocus, Bausch + Lomb, Bayer, Blackford Analysis, Freenome, Lucid Diagnostics, Masimo, Philips, Micromed, Natus, Pavmed, Veris Health. Read More

Regulatory actions for Jan. 18, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytovale, Magstim, Orthogen, Vyspine. Read More

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