Diagnostics: Page 6
-
Courtesy of Business Wire
Guardant posts data for colon cancer blood test amid push from rivals
The NEJM paper presents data from a study of more than 10,000 people Guardant ran to support authorization of its Shield DNA test.
By Nick Paul Taylor • March 18, 2024 -
Permission granted by QuidelOrtho
QuidelOrtho to lay off employees after firing CEO
Interim CEO Michael Iskra said in a recent presentation to investors the diagnostics firm plans to lay off less than 10% of its staff.
By Susan Kelly • March 14, 2024 -
Explore the Trendline➔
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 -
Stock via Getty Images
FDA panel backs Lumicell’s agent for breast cancer imaging tool
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
By Nick Paul Taylor • March 11, 2024 -
Courtesy of Dexcom
Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices
The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.
By Nick Paul Taylor • March 4, 2024 -
Permission granted by Becton Dickinson
BD life sciences president Dave Hickey to retire July 1
The company has yet to name Hickey’s replacement but plans to have a successor in place before the executive retires.
By Nick Paul Taylor • Feb. 28, 2024 -
iStock via Getty Images
Natera secures Medicare coverage for cancer test in 2 new indications
Natera met the coverage requirements for ovarian cancer in adjuvant and surveillance settings and for breast cancer in the neoadjuvant setting.
By Nick Paul Taylor • Feb. 27, 2024 -
Carl Court via Getty Images
European Council approves extension of IVDR transition
The Council expects the European Parliament to vote on the plan, without seeking amendments, in April.
By Nick Paul Taylor • Feb. 26, 2024 -
Permission granted by QuidelOrtho
QuidelOrtho fires CEO Doug Bryant
Bryant, who led the company since 2009, was fired after a challenging quarter and confusion over earnings forecasts.
By Elise Reuter • Feb. 21, 2024 -
UK medical device reviewers form new association
The group intends to help the medical device sector navigate a post-Brexit regulatory landscape.
By Susan Kelly • Feb. 20, 2024 -
K-Kwanchai via Getty Images
Freenome raises $254M to study cancer screening tests
Roche and Quest Diagnostics were among those to invest in the company’s development of early cancer detection blood tests.
By Nick Paul Taylor • Feb. 16, 2024 -
Getty Images via Getty Images
Invitae files for Chapter 11 bankruptcy
The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.
By Elise Reuter • Feb. 14, 2024 -
Courtesy of Cue Health Press Kit
Cue Health axes more jobs amid declining test sales
The company cut 94 workers at the beginning of last month and another 151 people on Jan. 25.
By Elise Reuter • Feb. 9, 2024 -
Permission granted by Illumina
Illumina cut 12% of global staff over past year: CEO
The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.
By Susan Kelly • Feb. 9, 2024 -
Courtesy of Illumina
Illumina to lay off 111 people at San Diego headquarters
The job cuts, expected by March 12, include senior management positions, scientists and engineers.
By Susan Kelly • Feb. 8, 2024 -
Stock via Getty Images
Invitae hires advisers, considers bankruptcy: WSJ
Sources told the Wall Street Journal a bankruptcy filing could come within weeks.
By Susan Kelly • Feb. 7, 2024 -
Sarah Silbiger via Getty Images
Hologic wins FDA clearance for AI-enabled cervical cancer screening system
The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.
By Nick Paul Taylor • Feb. 5, 2024 -
Permission granted by Veeva Systems
FDA to reclassify most high-risk IVDs, easing path to clearance
The effort comes ahead of the regulator’s plan to finalize a rule that would expand its oversight of laboratory-developed tests.
By Susan Kelly • Feb. 5, 2024 -
Joe Raedle/Getty Images via Getty Images
Califf backs increased LDT oversight despite industry opposition
At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.
By Ricky Zipp • Feb. 1, 2024 -
Courtesy of BD
BD partners with Techcyte to offer AI-enhanced cervical cancer screening
Techcyte has developed a system to reduce the amount of cells pathologists need to review.
By Nick Paul Taylor • Feb. 1, 2024 -
Permission granted by Agilent
Agilent, Incyte to partner on companion diagnostics
The collaboration comes after Agilent restructured and sold its liquid biopsy unit.
By Elise Reuter • Jan. 30, 2024 -
Courtesy of Abbott
Abbott says all four segments stronger than pre-pandemic
CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”
By Elise Reuter • Jan. 24, 2024 -
Carl Court via Getty Images
European Commission proposes delays for IVDR to prevent supply disruption
Officials are planning to give manufacturers another 31 months to get tests certified under the In Vitro Diagnostic Medical Devices Regulation.
By Nick Paul Taylor • Jan. 24, 2024 -
Nastassia Samal via Getty Images
Invitae sells reproductive health assets amid liquidity concerns
DNA testing firm Natera could pay up to $52.5 million total, and plans to move Invitae’s customers to its own tests.
By Elise Reuter • Jan. 22, 2024 -
Mario Tama via Getty Images
3 bellwether companies to watch as medtech earnings season begins
J&J, Intuitive Surgical and Abbott kick off this week with fourth-quarter reports.
By Nick Paul Taylor • Jan. 22, 2024 -
deliormanli via Getty Images
FDA, CMS defend plans to increase oversight of laboratory developed tests
In a joint letter Thursday, leaders from the agencies outlined why they are opposed to using the Clinical Laboratory Improvement Amendments to address concerns with LDTs.
By Nick Paul Taylor • Jan. 19, 2024
Previous
