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Home » Topics » Devices

Devices
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FDA Seeks Comments on Greater Access to Medical Technologies at Home

June 6, 2023
Public comment period closes Aug. 30. Read More

Novo Nordisk Buying Controlling Stake in BIOCORP for Its Smart Injector Pen

June 5, 2023
Novo Nordisk and BIOCORP have entered into negotiations for Novo Nordisk to acquire a controlling stake in BIOCORP, a French company which has been developing a Bluetooth enabled smart add-on device for insulin pen injectors. Read More

Legislative Update — Week of June 5, 2023

June 5, 2023

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business.

Read More

Ezra Sees 510(k) Clearance for Ezra Flash AI Product for Faster, Better MRI Images

June 5, 2023
The company’s preventive full-body scans have uncovered potential cancers and other disease states. Read More

FDA Seeks Comments on Greater Access to Medical Technologies at Home

June 2, 2023
As part of the FDA’s effort to increase access to home-use medical devices, CDRH is seeking comments from devicemakers, researchers, clinicians and the public on how to bring healthcare directly to patients wherever they are — at home, at work, in cities or in rural communities. Read More

FDA Issues Development Program Guidances to Assist Drug, Device Sponsors

June 2, 2023
The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential and request feedback from agency officials on device submissions under the Q-Submission program. Read More

FDA Says Devicemakers Should Prepare for Potential Hurricane Disruptions

June 2, 2023
Medical device manufacturers should prepare now for the potential disruption in fluctuating power, contaminants or unusual levels of heat or humidity that often occur during hurricane season, the FDA advises. Read More

Regulatory Update — Week of May 29, 2023

June 2, 2023
Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines. Read More

GE HealthCare Sees Clearance of Precision DL System to Enhance Scan Image Quality

June 2, 2023
The system improves detectability of small, low contrast lesions by 42 percent, the company said. Read More

FDA Cites Repeated Procedure and Document Issues at Theweb2u

June 1, 2023
Failure to resolve at least six of 10 observations from an earlier inspection resulted in another Form 483 in January for Theweb2u.com, maker of the Therapik insect bite and itch relief device. Read More

FDA Knocks Ward Photonics for Complaint Investigation Lapses

June 1, 2023
A Form 483 cites Cocoa Beach, Fla.-based Ward Photonics for continuing problems with investigation and evaluation of customer complaints for possible medical device report (MDR) requirements. Read More

Maiden Biosciences Gets 483 for Quality System Lapses

June 1, 2023
Maiden Biosciences received a Form 483 for quality system lapses after the FDA inspected the company’s Gaithersburg, Md., facility in November 2022. Read More
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