Reimbursement

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

The UK’s national rollout of hybrid closed loop (HCL) technologies marks NHS England as the global leader in providing equitable and fair access to next-generation diabetes management, Partha Kar, type 1 diabetes and technology lead, told Medtech Insight. Market leader Medtronic offers perspective.

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.

The pathway, which would be separate from breakthrough device reimbursement, would allow new AI technology to be reimbursed based on “clinical value and public stakeholder engagement.”

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

Representatives and individual experts taking part in joint assessments of new health technologies need to be free from conflicts of interest in relation to the industrial sector in which the health technology developer operates.

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

Medical products imported from China are among a broad range of items that will be subject to higher tariffs under new federal guidelines. The plan will raise tariffs on some forms of personal protective equipment (PPE) to 25%; additionally, tariffs on syringes and needles will be set at 50%.