AI-aided colon cancer tech gets FDA nod

Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system.

GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release.

The device, which received FDA approval through the de novo pathway, is compatible with all endoscopes. Cosmo is the sole manufacturer, while Medtronic is the exclusive worldwide distributor.

Made up of hardware and software designed to highlight portions of the colon, the device uses AI algorithms to identify regions of interest where it may detect a potential lesion. GI Genius generates markers, which appear as green squares and are accompanied by a short, low-volume sound. It superimposes them on the video from the endoscope camera when a potential lesion is identified.

The device’s signals alert a clinician …

Read more
  • 0

MedTech 100 roundup: Industry roars back

In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels.

MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark set a week prior (April 2).

The industry’s rebound has been impressive, given that just over one month prior, the index had dropped to 102.16 points (March 8), having just set its all-time best of 110.96 on Feb. 15. Medtech companies had no seen that degree of a fall since October 2020.

Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 18.5% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.1% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall …

Read more
  • 0

Medtronic stent graft recall is serious

The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind.

Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to provide a new path for blood to flow from the heart to the lower part of the body, according to an FDA release.

Get the full story at our sister site, Medical Tubing & Extrusion.

Read more
  • 0

Medtronic commits to helping people of color with diabetes

Medtronic (NYSE:MDT) announced today that it entered multiple partnerships to help improve health equity for people of color living with diabetes.

Fridley, Minn.-based Medtronic committed investments in partnerships with the American Diabetes Association (ADA) and the T1D Exchange, along with additional research efforts, to better understand and address such disparities, according to a news release.

The company is providing a $1 million sponsorship over the next three years to ADA’s Technology Access Project (TAP) which sets out to provide access and availability of diabetes technology regardless of gender, race, income or location.

“Health equity in diabetes is central to our mission, and unfortunately, for many the latest technological advancements to support living with the disease are not accessible due to insurance barriers and high out-of-pocket costs,” ADA chief development officer Charles D. Henderson said in the release. “…

Read more
  • 0

Medtronic kicks of newly expanded R&D center in India

Medtronic CEO Geoff Martha over videoconferencing helps inaugurate the MEIC with (left to right) Divya Prakash Joshi, senior director and site leader of MEIC; Shri KT Rama Rao, minister for Municipal Administration & Urban Development, Industries & Commerce, and Information Technology for the Indian state of Telangana; Shri Jayesh Ranjan, principal secretary, Industries & Commerce and IT; Shri Shakthi Nagappan, director of Life Sciences & Pharma, Telangana; and Madan Krishnan, VP and managing director of India Medtronic. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced the inauguration of its newly expanded 150,000 ft2 Medtronic Engineering and Innovation Center (MEIC) in Hyderabad, India.

The Fridley, Minn.–based medical device giant is spending $160 million over five years to turn Hyderabad into its largest R&D center outside the U.S. Medtronic expects the number of employees at the facility to reach 1,000.

Given the market s…

Read more
  • 0

Medtronic can’t shake suit over FDA clearance of spinal devices

(Image courtesy of Medtronic)

A federal appeals court has ruled that Medtronic must face a whistleblower lawsuit over FDA clearance of certain spinal fusion devices.

The Dan Abrams Company sued Medtronic in 2015 claiming that Medtronic defrauded the FDA into granting 510(k) clearance to certain Verte-Stack cervical vertebral body replacement (VBR) devices used in spinal fusion surgeries. The lawsuit also claims that Medtronic unlawfully marketed the devices for an off-label and contraindicated use, and illegally compensated physicians to use them.

Abrams also argues that these allegedly fraudulent practices caused physicians to submit false claims to Medicare. Dan Abrams Company is an LLC whose sole employee, Bryan Shapiro, formerly worked for Medtronic.  His “fraud-on-the-FDA” claim states that since Medicare reimbursement requires FDA clearance, the subject devices would have been ineligible for reimbursement but for Medtronic’s alleged fraud.

Read more
  • 0

DTW Podcast: Earnhardt shares how Abbott shifted gears to counter pandemic; Grail still looks to upend oncology

Abbott’s medical devices EVP Lisa Earnhardt discusses the life science giant’s pivot during the COVID-19 pandemic.

In this week’s DeviceTalks Weekly Podcast, Abbott’s medical devices EVP Lisa Earnhardt explains how the life sciences giant pivoted during the pandemic. Earnhardt shares what programs were given greater priority when the lockdown’s impact became clear and why the company performed so well in one of its key businesses.

We also explore this week’s news that the FTC will oppose Illumina’s acquisition of Grail through interviews with Dr. Christopher Keir, vice president of medical affairs at Grail, and Vijay Kumar, senior managing director at Evercore ISI.

And, of course, Chris Newmarker, executive editor of MassDevice, delivers this week’s Newmarker’s Newsmakers, including news from Illumina, Grail, Corindus, Zimmer Biomet, BD, Medtronic and Abbott.

Final…

Read more
  • 0

MedTech 100 roundup: Heading back to previous heights?

Although March brought on tough times for top stocks in the medtech industry, April is already showing signs of a rebound.

The year’s strong start, during which MassDevice‘s MedTech 100 index notched an all-time best of 110.96 points (Feb. 15) came to an end later that month and carried over into March, with the index hitting its lowest recent point on March 8 (102.16), marking a fall at a level not seen since October.

Even after a handful of slight improvements over the month of March, the industry never quite found its footing, ending the month below the 105-point mark.

The first week of April has already presented positive movement, though, with the industry rising to 106.26 points as the week ended on April 2, a 1.3% rise from the 104.87-point mark set the week prior on March 26.

Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry…

Read more
  • 0

DTW Podcast: Earnhardt shares how Abbott shifted gears to counter pandemic; Grail still looks to upend oncology

This week, we’ll talk with Lisa Earnhardt, executive vice president, medical devices at Abbott about how the life sciences giant pivoted during the pandemic.

This week, we’ll talk with Lisa Earnhardt, executive vice president, medical devices at Abbott about how the life sciences giant pivoted during the pandemic.

Earnhardt shares what programs were given greater priority when the impact of the lockdown became clear and why the company performed so well in one of its key businesses.

We also explore this week’s news that the FTC will oppose Illumina’s acquisition of Grail.

First, we talk with Dr. Christopher Keir, vice president of medical affairs at Grail, about the great potential of the company’s diagnostic technologies. The interview was recorded last month prior to the FTC’s decision.

Then we talk to Vijay Kumar, senior managing director at Evercore ISI, about why the FTC is making a strong case to block the deal.

And, of course, Chris …

Read more
  • 0

4 innovative devices delivered through catheters

[Images from Boston Scientific, Abbott, Edwards Lifesciences and Medtronic]Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw a number of FDA clearances and approvals for catheter-based technologies, including ones designed for conditions renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheter-based innovations by two major medtech companies. Two others developed for high-risk patients are worth revisiting.

Next >>
Read more
  • 0

4 innovative devices delivered through catheters

[Images from Boston Scientific, Abbott, Edwards Lifesciences and Medtronic]

Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw a number of FDA clearances and approvals for catheter-based technologies, including ones designed for conditions renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheter-based innovations by two major medtech companies. Two others developed for high-risk patients a…

Read more
  • 0

Medtronic veteran Brooke Story to lead BD’s Integrated Diagnostic Solutions

Brooke Story, soon-to-be worldwide president of BD Integrated Diagnostic Solutions

Another Medtronic veteran is leaving the company to take on new challenges elsewhere, and this time it involves BD.

Brooke Story will become worldwide president of BD Integrated Diagnostic Solutions, effective April 5. Story has been at Medtronic for 15 years, most recently serving as president of Pelvic Health and Gastric Therapies at the medtech giant.

At BD, Story will be in charge of worldwide strategic, operational and commercial performance and customer experience across a diagnostic continuum including specimen management, molecular diagnostics, microbiology, and women’s health and cancer. She’ll report to Dave Hickey, president of BD Life Sciences.

“Given the elevated importance of diagnostics during a pandemic, there is no better time for a leader like Brooke to join the BD team. Her passion for leading high-performing teams and her commitment to authentic l…

Read more
  • 0