Sternum recently announced a partnership with Medtronic to protect its legacy devices from cybersecurity threats. Medtech Insight chatted with its CEO Natali Tshuva about how her product works.

For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.

Stakeholders have access to the first version of the European Medical Device Nomenclature, an aid to identifying the precise type of device being referred to. And their views on the naming system are being sought too.

The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.

An FDA rule that says the agency will no longer regulate eight different types of medical software, an explainer of the FDA’s Remote Regulatory Assessments, high-risk class I recalls for medtech giant Medtronic, and more topped our list of most-read Medtech Insight articles in April.

Taiwan’s Medical Device Act was enforced on 1 May, bringing changes to good distribution practice and laying the foundation for UDI regulations.

For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.

A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”

An FDA rule that says the agency will no longer regulate eight different types of medical software, an explainer of the FDA’s Remote Regulatory Assessments, high-risk class I recalls for medtech giant Medtronic, and more topped our list of most-read Medtech Insight articles in April.

Sternum recently announced a partnership with Medtronic to protect its legacy devices from cybersecurity threats. Medtech Insight chatted with its CEO Natali Tshuva about how her product works.

During the first quarter, medical device company mergers and acquisition totalled $10.2bn, while in vitro diagnostic firms and research tools players completed M&A activity that totaled $5bn.

Inivata will remain a separate liquid biopsy division alongside NeoGenomics’ growing clinical, pharma and informatics divisions.

Baxter International recorded slight revenue increases during quarter one of 2021, with sales still impacted by COVID-19. Its board remains optimistic , pointing towards new product releases and “operational strength” as redeeming factors.

Labcorp has agreed to pay $150m in cash for Myriad Genetics’ autoimmune business, one of three major units Myriad is unloading as it tries to narrow its focus to oncology, women's health and mental health diagnostics.

Pelvalon CEO Miles Rosen talks the company’s journey from US FDA de novo authorization to Medicare HCPCS payment code for its Eclipse System, a nonsurgical device used for bowel control in women.

Omron is implementing its new VitalSight platform to physicians, hospitals for remote monitoring of high-risk hypertension patients at 50 US institutions and internationally. 

Medtronic teamed up with Surgical Theater to integrate its SyncAR technology with its StealthStation S8 surgical navigation platform to help neurosurgeons navigate complex brain surgeries.

In this week’s podcast, Medtech Insight managing editor Elizabeth Orr discusses the implications for medtech patent law from the US Supreme Court’s Minerva Surgical v. Hologic Inc. case, and senior reporter Ferdous Al-Faruque outlines the USPTO’s efforts to encourage inventors to file for COVID-19 product patents.

The agency has granted de novo authorization to Neurolutions’ IpsiHand System to help stroke victims rehabilitate the use of their upper extremity.

The government patent office has launched new COVID-19-related programs to get products to market faster and cheaper. But based on past experience, not a lot of companies are taking advantage of them.

The ROSA Partial Knee is part of Zimmer Biomet’s connected intelligence suite, which provides key analytics to health providers throughout a patient’s care continuum.