Orthofix names new global extremities president

Orthofix (NSDQ:OFIX) announced that it appointed Paul Gonsalves as the president of its global extremities business.

Gonsalves joins Lewisville, Texas-based Orthofix after previously serving as chief commercial officer at Integra LifeSciences (NSDQ:IART). He also served as senior VP of enterprise sales and corporate marketing at the medtech company.

Before his roles at Integra, Gonsalves served as senior VP and chief transformation officer with AccentCare and held the role of VP and GM of primary care at Novartis (NYSE:NVS), among a series of other roles including a handful at General Electric Healthcare (NYSE:GE).

In his new role, Gonsalves will also serve on the company’s executive leadership team while reporting to Orthofix president and CEO Jon Serbousek.

“Paul brings to Orthofix more than 30 years of industry experience and proven leadership that will both complement and strengthen our exceptional extremities management team,” Serbousek…

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Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke

Johnson & Johnson’s Cerenovus recently announced it has launched its new stroke solutions platform that includes three devices for clot removal procedures.

The three devices are designed to aid physicians in performing mechanical thrombectomy procedures. The devices include the Cerebase DA Guide Sheath, Cerenovus Large Bore Catheter and Embotrap III Revascularization Device.

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

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BD has a serious recall of some Alaris System infusion pumps with stuck keys

The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind.

Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between April 12, 2017 and June 25, 2020. A total of 305,526 devices have been recalled in the U.S., according to an FDA release.

BD is recalling the Alaris PC unit and the PC unit front case with keypad replacement kits because the keypad may have one or more keys in the keypad that become unresponsive or stuck, which could lead to an infusion delay or prevent clinicians from changing the fluid or medication infusions on the affected device.

Use of the affected Alaris infusion pump units could cause serious adverse events, including death, although no deaths have been reported to date. So far, there have been 1,186 reported complaints about …

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B-Temia wins FDA clearance for mobility exoskeleton

B-Temia’s Keeogo system (Image from B-Temia)

B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system.

Short for “keep on going,” Keeogo is a lower-limb-powered human mobility device with Dermoskeleton lightweight exoskeleton technology that provides what the Quebec City-based company describes in a news release as a “true human-machine interface.”

The Keeogo Dermoskeleton is designed to detect, respond to and support an individual’s movements with advanced software and motorized assistance. Based on individual needs, it offers mobility assistance, including complimentary knee strength and movement cues.

B-Temia’s system is intended for use by stroke patients who fit the user assessment criteria in rehabilitation settings under the supervision of healthcare professionals.

“The work we …

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B-Temia wins FDA clearance for mobility exoskeleton

B-Temia’s Keeogo system (Image from B-Temia)

B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system.

Short for “keep on going,” Keeogo is a lower-limb-powered human mobility device with Dermoskeleton lightweight exoskeleton technology that provides what the Quebec City-based company describes in a news release as a “true human-machine interface.”

The Keeogo Dermoskeleton is designed to detect, respond to and support an individual’s movements with advanced software and motorized assistance. Based on individual needs, it offers mobility assistance, including complimentary knee strength and movement cues.

B-Temia’s system is intended for use by stroke patients who fit the user assessment criteria in rehabilitation settings under the supervision of healthcare professionals.

“The work we …

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Varian names new president & COO among other personnel changes

Varian Medical Systems (NYSE:VAR) today announced a trio of personnel changes including the appointment of a new president and COO.

Effective Oct. 5, 2020, current Varian Oncology Systems president Chris Toth will take over the newly created roll of president and COO. As a result, current senior VP of global operations Kevin O’Reilly will take over as president of Varian Oncology Systems and VP of revenue operations Stephanie Foster will become senior VP of global supply chain operations.

“This announcement is a testament to the deep and diverse bench of talented leaders we have at Varian, as well as a reflection of our commitment to realizing our vision and strengthening our support for Varian’s customers and their patients,” Varian CEO Dow Wilson said in a news release. “I’m thrilled to congratulate Chris, Kevin and Stephanie on their expanded leadership roles, and I’m confident that they will ensure our entire team is well-positioned to build on Varian…

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Cala Health touts results of real-world tremor study

Cala Health today touted data demonstrating that its Cala Trio therapy is safe and effective in improving essential tremor in patients.

Burlingame, Calif.-based Cala Health said in a news release that the data for the wearable technology came from use at home, unsupervised and under real-world conditions, further validating the results reported in the Prospect study nearly one year ago.

Cala Health reported the results at the International Parkinson and Movement Disorder Society’s MDS Virtual Congress 2020, being held from Sept.12 to Sept. 16.

The data covered 44 patients using Cala Trio for symptomatic tremor relief in hand tremors over three months of unsupervised home use. Tremor severity was quantified through tremor power, which was collected through motion sensors and assessed before and after each of the first 40 therapy sessions and every subsequent seventh session.

According to Cala Health, 93% of patients experienced at least a 50% reduc…

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Hologic launches $950M private offering

Hologic (NSDQ:HOLX) announced today that it launched a private offering worth $950 million in senior notes due in 2029.

Marlborough, Mass.-based Hologic said in a news release that it plans to use the proceeds collected from the offering, along with available cash, to refinance its existing 4.375% senior unsecured notes due in 2025, with current cash earmarked for transaction-related premiums, fees and expenses.

The company expects to redeem all outstanding 2025 notes on or about Oct. 15, 2020, subject to the completion of the offering and the receipt of the proceeds, totaling an aggregate redemption price of nearly $970.8 million, plus a final interest payment.

Just last week, Hologic shares ticked up after news that the company boosted its financial outlook for the fourth quarter, improved from projections in its third-quarter results from July, coming on the back of reporting a strong third quarter boosted by COVID-19 test sales.

HOLX shares ha…

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CarThera collects $14.3M

CarThera announced today that it received a $2.3 million (€2 million) grant and $12 million (€10.5 million) in equity, totaling $14.3 million.

Paris-based CarThera was selected by the EIC Accelerator Pilot to receive the funds as it develops its Domeus project for treating glioblastoma patients. In addition to the money, CarThera is also slated to receive business coaching and mentoring through the accelerator, according to a news release.

The company’s Domeus project includes a multicenter, pilot clinical study for its SonoCloud-9 device designed to increase the intracerebral penetration of oncology drugs by transiently opening the blood-brain barrier without increasing dose or subsequent toxicity.

CarThera believes the project will lead to a scale-up in its processes and organizational structure and extend the functionalities of the SonoCloud device. Once completed, the project will transition the company’s status from a clinical-stage to a…

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Fitbit wins U.S., EU regulatory approval for ECG app

Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app.

San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release.

The Fitbit Sense wearable smartwatch is the company’s first device compatible with the ECG app, allowing users to hold their fingers to the stainless steel ring on the watch while holding still for 30 seconds to get a reading that can then be shared with a doctor.

With an on-wrist skin temperature sensor, an electrodermal activity sensor for managing stress and six or more days of batter life, the device is designed to help users control wellbeing on multiple fronts.

As part of its regulatory submission process, Fitbit conducted a multi-site clinical trial across the U.S. w…

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MedTech 100 roundup: Stocks brought back down again

A week after topping pre-pandemic highs, the medtech industry’s stocks were brought back down to earth in quick fashion.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 89.03 (Sep. 11), marking a -0.3% dip from the 89.29 points registered at the end of the week prior (Sep. 4).

However, the slight dip from week-to-week doesn’t show that, just before the Sep. 4 mark, medtech stocks had reached 93.11 points on Sep. 2, coming in nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.

During the week, the index dipped down to 88.22 points, which is the lowest total it has reached since it sat at 87.06 on July 16. By climbing back up to 89.03, the index now represents a -4.4% drop from the Sep. 2 high point and a -3.6% drop from the pre-pandemic high set on Feb. 19.

Meanwhile, the S&P 500 Index saw a -2.5% dip from Sep…

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Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S  and Boston Scientific (NYSE:BSX)  said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

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