Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.

The US Department of Health and Human Services said on 23 November that the money will be used “to enhance and expand the telehealth infrastructure and capacity of Title X family planning providers.”

The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.

The market for the reimbursement of digital health technologies is being held back because of the current fragmentation in reimbursement and funding. MedTech Europe is calling for change.

The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.

Single-patient lancets will face new special controls and 510(k) submission, while multiple-patient lancets would require a PMA.

Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.

The US FDA has posted a study affirming a safety communication the agency issued in October that warned of overdose risk from certain low dose tip syringes.

The US Food and Drug Administration has issued a warning to clinicians of the heightened risk for adverse events, including death, from potential cardiac perforation during implantation of Medtronic’s Micra Transcatheter Pacing System (TPS).

Bob Hopkins, previously the managing director at Bank of America Merrill Lynch, is now Medtronic's head of global strategy.

On this episode of Device Week, Medtech Insight’s Marion Webb explains the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Barnaby Pickering discusses recent results from the UK’s 100,000 Genome project, and how its analysis partner, Congenica, hopes to deliver personalized medicine through widescale genomic testing.

With approvals looming over the next few months, Angle spoke to Medtech Insight to probe deeper about its presentation at the 2021 Jefferies Healthcare Conference.

Cala Health’s FDA-cleared Cala Trio wearable for treating essential tremor is currently being tested in Parkinson’s disease patients and is targeting a $20bn global market opportunity.

A new analysis from Wells Fargo found that the big medtech stocks typically perform at least as well as the overall market when inflationary expectations are high, but 2021 defied that trend.

Naeotom Alpha will allow for faster, more precise, and safer computed tomography imaging for cardiac imaging, oncology, and pulmonology.

Cala Health’s FDA-cleared Cala Trio wearable for treating essential tremor is currently being tested in Parkinson’s disease patients and is targeting a $20bn global market opportunity.

Naeotom Alpha will allow for faster, more precise, and safer computed tomography imaging for cardiac imaging, oncology, and pulmonology.

The computer-based software helps predict how devices will react to increased temperature in MRI machines.

The first half of November was full of cardiovascular device news, led by clinical trial results from renal denervation and transcatheter aortic valve trials presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Johnson & Johnson expects that the new J&J unit will be better positioned to share expertise such as combing medical devices with drugs and continue to innovate.

Kaia’s digital therapy system will be available to users through a Luna On-Demand Physical Therapy, a provider of at-home physical therapy services.