Bardy Diagnostics names new CEO

BardyDx Carnation Ambulatory Monitor (CAM™) – P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection

Bardy Diagnostics announced that it appointed Kevin Hykes as its new president, CEO and member of its board effective Aug. 31, 2020.

Hykes has more than 28 years of experience in the medical device industry, having served as president and CEO of Relievant Medical Systems, Metavention and Cameron Health. Additionally, Hykes held roles as an operating partner at Revival Healthcare Capital and Versant Ventures, having previously held leadership positions at Medtronic, too.

His role includes responsibilities for leading the development and execution of short-term and long-term business and financial strategies while managing the overall operations of Bardy, according to a news release.

“I’m very excited and pleased to have Kevin join our executive team as Pr…

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DTW Podcast: KCK’s Long says deals getting done during COVID era

Karen Long, managing director at KCK Group

In this week’s DeviceTalks Weekly Podcast, Karen Long, managing director at KCK Group, says startups looking for funding have an opportunity to catch the eye and ear of investors.

KCK, an active medtech investor, has been involved in two sizable investments this summer including Aerin Medical and NeuroPace. Both were portfolio companies, but Long says KCK is in the market for new deals.

“We’re looking at companies and where we have the ability to take these ZOOM calls and take pitches that would have normally required a lot of travel and a lot of time to plan,” Long said in this week’s episode.”  We can do it in a half hour, 45 minutes and at least we have the introduction and can see if it makes sense to continue.”

Medtech executives looking for more insight on the fundraising market can register for today’s DeviceTalks Tuesday discussion where …

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DTW Podcast: KCK’s Long says deals getting done during COVID era

Karen Long, managing director at KCK Group

In this week’s DeviceTalks Weekly Podcast, Karen Long, managing director at KCK Group, says startups looking for funding have an opportunity to catch the eye and ear of investors.

KCK, an active medtech investor, has been involved in two sizable investments this summer including Aerin Medical and NeuroPace. Both were portfolio companies, but Long says KCK is in the market for new deals.

“We’re looking at companies and where we have the ability to take these ZOOM calls and take pitches that would have normally required a lot of travel and a lot of time to plan,” Long said in this week’s episode.”  We can do it in a half hour, 45 minutes and at least we have the introduction and can see if it makes sense to continue.”

Medtech executives looking for more insight on the fundraising market can register for today’s DeviceTalks Tuesday discussion where …

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Titan Medical CFO retires; succesor named

Titan Medical (TSX:TMD;OTC:TITFX) announced today that CFO Stephen Randall will retire and Monique Delorme will assume the role.

Randall has spent more than 10 years with Titan Medical, leading the company through 30 capital transactions and raising more than $260 million to fund research and development for its surgical robotic technologies, according to a news release.

“For the past 10 years, Stephen has played a pivotal role in Titan’s journey from an early-stage startup to become a leader in single-port robotic surgical technologies,” Titan Medical CEO David McNally said in the release. “Stephen’s leadership, guidance and unwavering commitment to Titan has been vital to our business – and for that we thank him.

“I am also pleased that Stephen will remain with the company in his capacity as a director of the board and will continue to guide the company toward realizing its vision for improving patient outcomes with its single-port robotic …

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InspireMD wins FDA approval for carotid stent system study

InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System.

The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S.

Get the full story on our sister site, Medical Tubing + Extrusion.

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UK recommends Axonics SNM for overactive bladder

Axonics Modulation Technologies (NSDQ:AXNX) announced today that NICE suggested using its r-SNM system in the UK.

The National Institute for Health and Care Excellence (NICE) offers evidence-based guidance to the UK and, in guidance published last week, it recommended Axonics’ sacral neuromodulation (SNM) system for treating refractory overactive bladder for the country’s National Health Service (NHS).

NICE’s guidance claimed that, based on clinical evidence, the r-SNM system improves symptoms and quality of life while providing longer battery life than the non-rechargeable system currently used by the NHS. Additionally, NICE’s cost modeling estimates that the r-SNM system would save more than $7,850 (£6,025) per person, beginning about six years after implant.

The evaluation also determined that Axonics’ battery life of 15 years or more will likely reduce the number of avoidable replacement procedures a patient may need to …

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Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly dem…

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ParaGen Technologies raises $4.1m

ParaGen Technologies filed an amendment to an SEC Form D last week confirming the sale of more than $4.1 million.

Columbus, Ohio-based ParaGen is offering a total of $10 million in equity and options, warrants and/or other rights to purchase securities. Following its sale of $4.1 million, the company still has nearly 5.8 million remaining to be sold.

The first sale in the offering came on June 11, 2019, and 27 total investors have participated so far. The company does not expect the offering to last longer than one year, according to the filing.

ParaGen did not list an intended use of proceeds, but the company is developing a platform scaffold technology that uses tissue engineering to address biologic and synthetic implants. Its four portfolio companies include RenovoDerm, Atreon Orthopedics, Vascular Genesis and Tarian Medical. Each company is making products for wound care, orthopedic, peripheral vascular and hernia markets.

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MedTech 100 roundup: Stocks top pre-pandemic high

After weeks of flirting with the heights hit before COVID-19 ravaged the markets, medtech stocks finally topped the pre-pandemic high last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — spiked up to 93.11 points on Sep. 2, nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.

Medtech stocks had hit a previous mid-pandemic high of 91 points last week, hanging around there before the sudden rise to 93.11, which was followed by a quick dip to 90.64 points 24 hours later.

The index dipped from that peak, though, sitting at 89.29 points at the end of last week (Sep. 4). Overall, medtech stocks saw a -1.6% decrease from the 90.78-point total at the same time a week prior (Aug. 28).

The most recent high mark represents a 0.9% rise from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -3.3% decrease from that pre-pande…

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How decontamination could solve the COVID-19 mask shortage problem

With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks.

(Image courtesy of Brian McGowan on Unsplash)

A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks.

Hundreds of frontline healthcare workers have died from the virus since the pandemic struck in China in 2019, bringing the need for effective face masks into sharp relief. But despite the efforts of 3M and other companies worldwide to boost production of the most effective filtering masks — N95s — there still might not be enough.

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

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Biden is getting the most money from medtech employees

Medtech company employees and their families have donated $289,533 to former Vice President Joe Biden, versus $190,570 for President Donald Trump, according to OpenSecrets.org. Check out our breakdown covering 25 of the largest companies.

[Image courtesy of Biden for President]

Medical device company employees’ preference in the U.S. presidential election appears to be clear: They’re providing more money to the Democratic presidential nominee Joe Biden, according to campaign contribution data compiled by the nonpartisan, nonprofit Center for Responsive Politics’ Opensecrets.org.

The difference is even starker when adding donations to other Democrats who failed to secure the nomination.

As of June 30, employees and their families at 25 major medtech companies had donated nearly $1.1 million. Biden received 26.6%, Bernie Sanders received 21.6%, Trump received 17.5%, Elizabeth Warren received 11%, Pet…

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The top 5 MassDevice stories of the week — September 4, 2020

Medtronic (NYSE:MDT) and a major development involving medtech reimbursement dominated medical device industry news over the past week.

As the week closes out, there’s also a trending story on MassDevice that includes good news: Abbott (NYSE:ABT) is reportedly hiring 2,000 new employees in Illinois to increase manufacturing for its rapid COVID-19 test.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. FDA approves Medtronic MiniMed 770G insulin pump for young children

The FDA has approved the Medtronic MiniMed 770G  hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose mon…

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