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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Jan. 25, 2024

View Archived Issues
LIBERTA DBS

FDA frees Abbott’s Liberta RC DBS system for use

Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday. Read More
Allurion Balloon

Allurion’s swallowable gastric balloon introduced into the UK NHS

A U.K. national health service (NHS) hospital has begun offering Allurion Technologies Inc.’s swallowable gastric balloon to patients struggling to lose weight for surgery. The move is a boon for the company amid rising competition in the weight loss market from GLP-1 agonists. Read More
3D illustration of ovarian cancer cells.

Cleo’s blood-based ovarian cancer test diagnoses deadly cancer earlier

Ovarian cancer diagnostics company, Cleo Diagnostics Ltd. has developed a blood-based diagnostic test for ovarian cancer based on the CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in nonmalignant disease. Read More
Digital brain and silhouette

FDA’s device center meets MDUFA hiring goals in fiscal 2023

The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023. Read More
Hematology.png

With series A funds, IMU Bio’s Cytatlas identifies cell types and immune signatures

IMU Biosciences Ltd. has raised £11.5 million (US$14.7 million) in a series A round to further develop and commercialize profiling technology that can identify from a blood sample which of more than 2,000 cell types are present in an individual’s immune system. Read More
Gavel-and-scales.png

Device maker convicted for forgery of FDA documents

The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory. Read More

Appointments and advancements for Jan. 25, 2024

New hires and promotions in the med-tech industry, including: Endologix, Inogen, Pelago, Theragenics. Read More

Financings for Jan. 25, 2024

Med-tech firms raising money in public or private financings, including: Circular Genomics, Isaac Health, 2GHealth. Read More

In the clinic for Jan. 25, 2024

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

Other news to note for Jan. 25, 2024

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aifred, Amerisourcebergen, BD, Bruker, Cencora, Centogene, Chemspeed, Debiopharm, Genialis, Intelligent Bio, Sigrid Therapeutics, SS Innovations. Read More

Regulatory actions for Jan. 25, 2024

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Able Medical, Absolutoins, Croívalve, Enhatch, Intuitive Surgical. Read More

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