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7 startups grabbing the medtech spotlight in Minnesota

Minnesota has long been one of the nation’s top three medtech hubs and a good place for startups to get their footing.

For 17 years, the MN Cup contest has offered cash prizes and the opportunity for medtech (and other) startups to tap into expert help to accelerate their businesses. MN Cup is a community-led, public-private partnership that brings together corporations, venture capital firms, foundations, government and volunteers. This year’s crop of medtech semifinalists includes some names that may be familiar to readers of Medical Design & Outsourcing.

Get the full story on our sister site, Medical Design & Outsourcing.

Carbon Health acquires Steady Health and its diabetes platform

Carbon Health announced today that it acquired Steady Health and its platform for using continuous glucose monitoring to personalize diabetes care.

San Francisco-based Carbon Health said in a news release that the acquisition accelerates its rollout of a new primary care model designed to integrate its clinic footprint with virtual and hardware-enabled capabilities to create high-quality, accessible healthcare.

Get the full story at our sister site, Drug Delivery Business News.

Zenflow raises $24M for minimally invasive urinary obstruction treatment

Zenflow announced over the past week that it has raised $24 million in a Series B round.

The South San Francisco, Calif.–based company — which has a minimally invasive treatment for urinary obstruction caused by an enlarged prostate — also appointed Susan Stimson as its president. Stimson was a founding member of ear, nose and throat medtech company Intersect ENT and most recently served as executive in residence with KCK Group.

Money from the new financing round will go toward a pivotal clinical trial meant to ultimately lead to FDA clearance of Zenflow’s Spring system, which uses a small spring-like coil to gently prop open the urethra.

“The Zenflow Spring clinical trial data thus far demonstrates promising outcomes with respect to patient symptom relief, urinary flow rates and preservation of sexual function,” said Dr. Claus Roehrborn, chair of the Department of Urology at UT Southwestern Medical Center in Dallas. “Once proven further through it…

Philips touts 2-year data for Tack endovascular system

[Image from Philips]Royal Philips (NYSE:PHG) today announced positive two-year results from a clinical trial of the Tack endovascular system.

Amsterdam-based Philips presented data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial at the 2021 New Cardiovascular Horizons Conference, according to a news release.

Data presented by co-principal investigator Dr. George Adams, an interventional cardiologist at Rex Hospital (University of North Carolina, Chapel Hill) demonstrated a sustained treatment effect and a positive impact on quality of life for patients with peripheral artery disease (PAD) and critical limb ischemia (CLI) treated with the Tack dissection repair device, which Philips acquired when it bought Intact Vascular for $275 million in August 2020.

Tack, a specialized, implantable device designed to optimize the treatment of dissections in patients with PAD and CLI, provided 73.6% of patients freedom from clini…

AliveCor purchases CardioLabs

Personal ECG tech company AliveCor is acquiring CardioLabs and its monitoring and cardiac diagnostic services.

The financial terms of the deal were not disclosed in yesterday’s news release.

“The acquisition of CardioLabs sets AliveCor on a course to becoming the premier provider of end-to-end cardiac diagnostic support,” AlilveCor CEO Priya Abani, said in the news release. “We are creating new opportunities for healthcare providers and patients through enhanced, reimbursed cardiac monitoring services and access to real-time data that helps inform clinical decision-making.”

AliveCor is now the manager of CardioLabs’ U.S.-based healthcare provider customers and plans to expand the service to new customers in the coming months.

Existing CardioLabs customers will keep their access to mobile cardiac telemetry, cardiac event monitoring, extended Holter and Holter monitoring. Longer-term, AliveCor will make its Kardia…

Dexcom touts CGM studies, shares data on next-gen G7

Dexcom (NSDQ:DXCM) today shared results from two studies of continuous glucose monitors, including its next-generation G7 CGM.

San Diego-based Dexcom presented the studies during the 14th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).

Get the full story at our sister site, Drug Delivery Business News.

FDA clears Medtronic patient-specific spinal rods

Medtronic (NYSE:MDT) today announced its UNiD patient-specific rods for its spinal systems won FDA clearance.

The UNiD rods are made for use with the Dublin, Ireland-based company’s CD Horizon Solera Voyager and Infinity OCT spinal systems, which can be used in combination with the Mazor robotic system.

Medtronic designed the rods to be industrially pre-bent prior to surgery to accurately match an artificial intelligence-driven, pre-operative surgical plan created by the UNiD adaptive spine intelligence (ASI) technology. The rods and ASI technology work to precisely align patients’s spines to reduce the risk of malalignment and associated revision surgeries, according to the company.

“Being able to integrate powerful complementary technologies — AI, robotics and patient-specific implants — is the future of spine surgery and will change spine care for the better by streamlining my workflow and reducing surgical uncertainty,&#…

Abiomed buys PreCardia and its heart failure treatment system

Abiomed (NASDAQ: ABMD) announced this week that it has acquired PreCardia and its catheter-based system to treat acute decompensated heart failure.

The financial terms of the deal were not disclosed in the June 1 announcement.

Abiomed officials say the deal complements the company’s product portfolio, expanding options for patients with acute decompensated heart failure.

The PreCardia system is meant to quickly reduce congestion in the venous system to improve overall cardiorenal function. The technology includes a balloon catheter and pump controller to address acute decompensated heart failure through the intermittent superior vena cava occlusion.

St. Paul, Minn.–based PreCardia won FDA breakthrough device designation for its system in June 2020.

“We look forward to advancing PreCardia’s technology through the regulatory process and expanding our relationship with heart failure specialists to help improve outcomes in early-stage acu…

DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation

Josh Makower, MD, quite possibly invented modern day medtech innovation.

In this interview, Makower shares his earliest inventions – kind of mind-blowing – and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this fall.

This interview is essential for any individual or organization that wants to innovate. Dr. Makower will share his thoughts on how innovation in any industry should be approached.

This week we’ll explore innovation and social equity. We’ll hear a portion of an interview with Martha Ha, chief privacy officer and chief counsel of corporate governance, and Jon de Csepel, CMO, vice president, medical affairs of the Americas. The pair will explain how the company is reaching out to employees of Asia and Pacific Island and helping them to understand how to better work within the corporate culture. The …

HHS wants investors to help prevent next pandemic

U.S. Department of Health and Human Services (HHS)

The U.S. Department of Health and Human Services (HHS) is turning to venture capital to speed the development of medical devices to stave off or fight public health emergencies.

HHS’s Biomedical Advanced Research and Development Authority (BARDA) plans to provide the nonprofit Global Health Investment Corporation (GHIC) with a minimum of $50 million over five years, with potential for up to $500 million over 10 years. GHIC will start a global health security fund with matching capital from other investors to identify, nurture and commercialize breakthrough technologies to aid the U.S. in responding effectively to future health security threats, according to HHS.

Get the full story on our sister site, Medical Design & Outsourcing.

Report: FTC drops Illumina-Grail court case

A U.S. judge reportedly ruled in favor of an FTC petition to drop its case against the proposed merger between Illumina (NSDQ:ILMN) and Grail.

The Financial Times reported that the ruling allows Brussels to investigate the merger while the deal remains blocked. In April the European Commission’s Directorate-General for Competition announced today that it will review Illumina’s proposed $8 billion acquisition of Grail.

Illumina and Grail agreed this spring to postpone the planned purchase until after Sept. 20 while the FTC challenged the deal. The company in March stated that it disagreed with and will oppose the FTC’s challenge to the acquisition of Grail, a cancer detection startup that spun out from the company four years ago.

According to the FT report, Illumina CEO Francis deSouza claims that the U.S. regulators are employing “time-wasting” maneuvers and that the companies want the FTC to operate with a sense of urgency to get the case to…

Medtronic stops sales of its HVAD system, Abbott confirms capacity for HeartMate 3 demand

Medtronic’s HVAD [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it has stopped the distribution and sale of its HeartWare Ventricular Assist Device (HVAD) system.

Fridley, Minn.-baed Medtronic this morning issued a notice to physicians informing them to stop new implants of the HVAD system and to transition to an alternative means of durable mechanical circulatory support, according to a news release.

The company said it is developing a support program for patients who had an HVAD implanted to ensure the ongoing care and safety of such patients, of which there are approximately 4,000.

Medtronic said the decision came in light of a number of clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system. In February, the company recalled the device after 855 complaints and eight injuries related to an issue with the device’s ports. Medtronic reported …