Diagnostics: Page 2
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EU medtech regulations reducing options for patients, companies say
Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”
By Nick Paul Taylor • Jan. 13, 2025 -
Mario Tama / Staff via Getty Images
Top 10 medtech deals of 2024
Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical.
By Nick Paul Taylor • Jan. 2, 2025 -
Explore the Trendlineâž”
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Justin Sullivan via Getty Images
Labcorp closes takeover of Ballad Health outreach laboratory services
Labcorp continued its streak of hospital lab purchases with a deal that will expand its testing capabilities to communities in Tennessee, Virginia, North Carolina and Kentucky.
By Nick Paul Taylor • Dec. 12, 2024 -
Courtesy of GuardantHealth
Guardant awarded nearly $293M in false ad trial against Natera
Natera allegedly made “false and misleading statements” to convince people to use its Signatera cancer test rather than Guardant’s rival product Reveal.
By Nick Paul Taylor • Dec. 2, 2024 -
Spencer Platt/Getty Images via Getty Images
Medtronic wins VA contract to install AI-powered endoscopy units
The three-year contract expands Medtronic’s work with the VA to cover the installation of almost 100 more GI Genius endoscopy modules at U.S. centers.
By Nick Paul Taylor • Nov. 26, 2024 -
Permission granted by Labcorp
Labcorp hires Julia Wang as CFO
Wang will replace Glenn Eisenberg, who is retiring after 10 years in the role. Evercore analysts called Eisenberg a Labcorp “institution.”
By Susan Kelly • Nov. 20, 2024 -
Retrieved from GE Healthcare on November 14, 2024
GE Healthcare’s head-only MRI scanner cleared by the FDA
The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.
By Nick Paul Taylor • Nov. 14, 2024 -
Kimberly White/Getty Images via Getty Images
23andMe to lay off more than 200 employees amid business struggles
The genetic testing firm will also close its therapeutics arm. CEO Anne Wojcicki said the cuts are necessary to “focus on the long-term success of our core consumer business.”
By Ricky Zipp • Nov. 13, 2024 -
Win McNamee/Getty Images via Getty Images
Advamed CEO congratulates Trump, stresses need for public policy support
Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.
By Ricky Zipp • Nov. 11, 2024 -
Courtesy of Exact Sciences
Exact Sciences’ forecast cut shocks analysts
The lowered sales forecast, which analysts called a “shocking guidance update,” contributed to a 23% drop in the cancer screening company’s stock on Wednesday.
By Nick Paul Taylor • Nov. 8, 2024 -
Courtesy of Ambry Genetics
Tempus AI to buy genetic testing company for $600M
CEO Eric Lefkofsky said the purchase of Ambry Genetics will expand Tempus’ testing portfolio and bring in a fast-growing business.
By Elise Reuter • Nov. 6, 2024 -
Thomas Andreas via Getty Images
Advamed asks CMS to cover extra imaging of dense breast tissue
Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.
By Nick Paul Taylor • Nov. 6, 2024 -
Carl Court via Getty Images
European Parliament calls for proposals to reform MDR and IVDR by end of Q1
Parliament asked the European Commission to publish acts that address the “most pressing challenges and bottlenecks” of the regulations and propose the “systematic revision” of the legislation.
By Nick Paul Taylor • Oct. 24, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceMedtech Conference recap: New CDRH leader details approach; AI and LDTs in focus
Catch up on our recent coverage of Advamed’s The Medtech Conference.
By Elise Reuter • Oct. 23, 2024 -
Permission granted by GE Healthcare
GE Healthcare opens AI Innovation Lab to grow new projects
The AI Innovation Lab is designed to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.
By Nick Paul Taylor • Oct. 22, 2024 -
Deep Dive
5 steps to navigate the FDA’s new lab developed test rule
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.
By Susan Kelly • Oct. 21, 2024 -
Sarah Silbiger via Getty Images
FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Alxpin via Getty Images
Medtech Europe calls for urgent reform of MDR and IVDR
The trade group’s intervention follows news that the new commissioner for Health and Animal Welfare will assess the need for legislative changes.
By Nick Paul Taylor • Oct. 18, 2024 -
Courtesy of Metro Toronto Convention Centre
The Medtech Conference4 trends to watch at Advamed’s The Medtech Conference
As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.
By Elise Reuter • Oct. 14, 2024 -
Courtesy of Exact Sciences
Exact Sciences wins FDA approval for Cologuard Plus colorectal cancer test
Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.
By Nick Paul Taylor • Oct. 7, 2024 -
Stringer via Getty Images
GE Healthcare gets FDA nod for new PET imaging agent
Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.
By Susan Kelly • Oct. 1, 2024 -
halbergman via Getty Images
Top medtech conferences in 2025
The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.
By Ricky Zipp • Updated Jan. 23, 2025 -
Tom Brenner via Getty Images
Congress again delays steep cuts in Medicare lab payments
The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.
By Susan Kelly • Sept. 26, 2024 -
Sarah Silbiger via Getty Images
FDA proposes reclassifying hepatitis B assays
The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.
By Nick Paul Taylor • Sept. 26, 2024 -
Courtesy of Roche
Roche launches test that detects 12 respiratory viruses
Roche’s TAGS technology allows tests to simultaneously detect multiple respiratory viruses, including influenza A and B, RSV and the COVID-19 virus.
By Nick Paul Taylor • Sept. 25, 2024
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