The Latest
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Boston Scientific unveils plans for new Watchman device
The company hopes to launch its next-generation Watchman system in the second half of 2027 or early 2028.
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Medtech firms splitting into ‘haves’ and ‘have-nots’: EY
The number of medtech funding rounds has declined in recent months, but the value of overall deals has increased, according to a new report from EY.
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HHS plans to furlough more than 40% of staff if government shuts down
Under the contingency plan, the CMS would lose 47% of its staff, while the CDC and the NIH would lose 64% and 75%, respectively.
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FDA expands early alert program to cover all medical devices
After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events.
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EssilorLuxottica wins FDA OK for myopia-slowing eyeglass lenses
Investigators saw a 71% reduction in myopia progression in children who used the lenses for two years.
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MedTech Europe pressures EU to make regulatory changes by early 2026
The request includes a call to postpone re-certification requirements for devices already certified under the medical technology regulations.
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SS Innovations hires new CFO
Naveen Kumar Amar joins the surgical robot developer as it prepares to expand globally, including in Europe and the U.S.
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Biolinq gets FDA de novo nod for intradermal glucose sensor
The device, called Biolinq Shine, is indicated for people with Type 2 diabetes who don’t depend on insulin.
Updated Sept. 29, 2025 -
Section 232 probe reignites tariff uncertainty for medtech firms
The Trump administration has used the investigations in other sectors to implement tariffs, but the earliest any potential actions would take place is summer 2026, analysts said.
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Q&A
Que Dallara on Medtronic’s diabetes spinoff, pipeline and Abbott partnership
Dallara, president of Medtronic’s diabetes business, discussed the segment’s turnaround and why she sees a benefit in becoming a standalone firm.
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Heartflow receives FDA clearance for updated plaque analysis platform
The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.
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Quest to distribute Guardant colon cancer blood test
Guardant Health Co-CEO AmirAli Talasaz also unveiled plans to launch the Shield test for multi-cancer detection in October.
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US opens investigation into medical equipment, device imports
As part of the Section 232 probe, the Trump administration will weigh the need for tariffs on goods such as surgical masks, blood glucose monitors and wheelchairs.
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Medtronic expands AI, robotics hub in London; Virtuoso robot gets FDA breakthrough status
The Medtronic center will facilitate surgeon collaboration and AI-powered decision support. At Virtuoso Surgical, a robotic approach to bladder lesion removal is expected to improve precision.
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J&J’s Abiomed starts third heart pump controller recall since June
As of Aug. 27, the company had reported five serious injuries and no deaths associated with the issue.
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Cardiosense names Eric Meizlish as CEO
Cardiosense’s switch to a leader with experience scaling healthtech companies comes as it works to build on the recent 510(k) clearance of CardioTag.
Updated Sept. 25, 2025 -
Profile
How SS Innovations is expanding robotic surgery’s reach
Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in more than 5,000 surgeries.
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Retrieved from Johnson & Johnson on September 23, 2025
J&J exits Linx esophageal reflux business in some countries
Johnson & Johnson, which said it made the decision based on a market assessment, did not specify the markets it is leaving or provide a timeline. Linx will remain available in the U.S.
Updated Sept. 24, 2025 -
Olympus removes needles after patient death
Olympus is recalling certain lots of needles, used for lung cancer biopsy, because components can detach during procedures.
Updated Oct. 1, 2025 -
Multi-cancer blood tests aren’t ready for routine use, review says
Research funded by the Agency for Healthcare Research and Quality found insufficient evidence to determine the accuracy — or possible harm — of the cancer screenings.
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White House asks Supreme Court to uphold Trump’s tariff powers
The government submitted a 49-page brief urging the high court to affirm Trump's broad emergency levies.
Updated Sept. 22, 2025