Abbott Archives - Page 27 of 34 - Medical Design Sourcing

Abbott halts heart pump trial

(Image courtesy of Abbott)

Abbott (NYSE:ABT) has halted a clinical trial comparing its HeartMate II ventricular assist device with the Abiomed (NSDQ:ABMD) Impella heart pumps.

The Abbott Park, Ill.-based company suspended enrollment in the Shield II investigational device exemption study after a report of decreased impeller speed at the end of a procedure.

The HeartMate II is a high-speed rotary blood pump that produces an axial flow and therefore no pulsatile action. The impeller is its only moving part, which spins at rates between 2,000 and 3,000 revolutions per minute, according to the University of Michigan Frankel Cardiovascular Center.

“The impeller is suspended within the pump housing through a combination of passive magnets and a hydrodynamic thrust bearing,” the university’s website says. “This hydrodynamic suspension is achieved by a gentle incline on the upper surfaces of the impeller blades. When the impeller spins, …

DTW Podcast: Insulet CEO Petrovic sees abundance of CGM opportunities

Insulet CEO Shacey Petrovic shares vision for OmniPod insulin delivery.

Medtech start ups developing continuous glucose monitors have caught the eye of at least one potential – and powerful – partner – Insulet Corp.

In an interview with the DeviceTalks Weekly Podcast, CEO Shacey Petrovic said the maker of the OmniPod insulin-delivery device sees partnering with other companies as the likely path to creating a single device capable of reading glucose levels and delivering insulin. Insulet last year announced partnerships with DexCom and Abbott.

“There are some really interesting technologies on the horizon,” Petrovic said. “There might be 40 early-stage CGMs in development so we’ll see how the market plays out. But we couldn’t be more delighted with our partnerships with Abbott and Dexcom.”

The partnerships give Insulet access to technology that’s able to measure glucose levels in…

5 at-home COVID-19 diagnostic tests you should know

The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home.

The agency has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms are advised to follow up with their healthcare providers as a negative result does not rule out a SARS-CoV-2 infection.

<…

MedTech 100 roundup: Industry rebounds from massive dip

The medtech industry saw its largest fall in several months last week, but it has rebounded slightly after a couple of bad weeks.

A strong start to 2021 hit a skid at the end of February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a precipitous fall not seen since October.

While the heights of last month have not yet been returned to, the industry has shown signs of bouncing back. The index ended the week (March 12) at 104.62, marking a 1.3% rise from the 103.3-point mark set one week before (March 5).

The industry remains in a strong position and one that is particularly stronger than it was at this time a year ago, as the index is now 13.3% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.

Nearly one year ago, on March 23, 2020, as the pandemic took hold, the industry sat at 62.13 points on th…

DTW Podcast: CEO Petrovic explains how Insulet is switching people to `Pods

Insulet CEO Shacey Petrovic says she didn’t jump immediately at the chance to join the company.

In an interview with the DeviceTalks Weekly Podcast, Petrovic, who was serving as CEO of a women’s health company when CEO-Patrick Sullivan, her former boss at Cytyc, called her with an offer to serve as Insulet’s chief commercial officer

“I said, `Well, Pat, I’m a CEO now, you know, didn’t you hear?,” she joked.

A chief commercial officer role might be seen as a backward step from CEO, but Sullivan framed the question differently. He told Petrovic that he came out of retirement to take the CEO role and didn’t want to a long stint as CEO. “He said, `This could be your opportunity to eventually run a public company. If it goes well, I need a successor, the technology is remarkable, and together we can fix this problem.’”

A path the CEO role at a publicly traded company was certainly appealing. But Petrovic had more personal reason for the jo…

Abbott announces pandemic defense coalition

Abbott (NYSE:ABT) announced today that it formed the Abbott Pandemic Defense Coalition for future pandemic threats.

The first-of-its-kind global scientific and public health partnership is dedicated to the early detection of and rapid response to future pandemic threats through the connection of global centers of excellence in laboratory testing, genetic sequencing and public health research, according to a news release.

Abbott Park, Ill.-based Abbott’s coalition will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing and assess public health impact in realtime as the COVID-19 pandemic reaches the one-year mark.

Included in the coalition’s efforts will be a public database for publishing sequences of viruses so health officials and laboratories can work together to identify if it’s a novel strain or a virus that has previously been detected.

The process to identify potential ne…

How CGM tech has advanced in the 21st century

The rapid evolution of the continuous glucose monitor (CGM) has brought flexibility and convenience to diabetes control.

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Efforts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care.

Elkhart, Ind.–based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer. The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices.

In the 1970s, Ames developed a device known as the Ames Reflectance Meter to m…

How CGM tech has advanced in the 21st century

The rapid evolution of the continuous glucose monitor (CGM) has brought flexibility and convenience to diabetes control.

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Efforts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care.

Elkhart, Ind.–based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer. The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices.

In the 1970s, Ames developed a device known as the Ames Reflectance Meter to m…

5 at-home COVID-19 diagnostic tests you should know

[Image from unsplash.com]

A year into the COVID-19 pandemic, the wait for a completely at-home COVID-19 test ended when the FDA authorized the first ones in November to enable people to obtain samples and results at home.

The FDA has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms …

Abbott launches real-time remote neuromodulation tech

(Image courtesy of Abbott)

Abbott (NYSE:ABT) announced today that the FDA has approved a neuromodulation treatment platform that allows physicians to communicate with patients and monitor or change their treatment in real-time.

The NeuroSphere Virtual Clinic could increase access to treatment for patients with chronic pain or movement disorders who don’t live close to a care provider, have difficulty accessing care, or are unable to go to the doctor because of circumstances like COVID-19, according to the company.

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

Former Abbott sales director’s age discrimination suit can proceed

[Image from Unsplash]A New Jersey federal judge has ruled that an age bias lawsuit from a former sales director at Abbott (NYSE:ABT) can move forward.

Richard Rudolph alleged that, after 15 years as a sales director at the Abbott Park, Ill.-based medtech company, he was let go because of his age at 55 years old.

Rudolph claimed that the company laid out unreasonable performance goals to create an opportunity to force him out. Targets referred to by Rudolph — and whether he achieved them — are subject to dispute between him and his supervisor at Abbott, U.S. District Judge Peter G. Sheridan wrote in his order denying Abbott’s motion for summary judgment.

Abbott required Rudolph to achieve specific sales performance requirements each month in three regions, make three 30-day sales forecasts with more than 90% accuracy, deliver 100% accurate and current Salesforce.com data at the end of each month and grow distribution partner McKesson’s ambulatory…

Abbott wins EUA for COVID-19, flu, RSV combo assay

Abbott (NYSE:ABT) announced today that it received FDA emergency use authorization (EUA) for its Alinity m Resp-4-Plex molecular assay.

The laboratory PCR diagnostic is designed to detect and differentiate between SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) in one test. It already has CE Mark approval and is available in other countries outside the U.S., according to a news release.

Abbott Park, Ill.-based Abbott’s Alinity m Resp-4-Plex test uses one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or self-collected at a healthcare location. The test will run on Abbott’s Alinity m system using PCR technology.

The company said that, along with providing diagnostic results for four separate viruses, offering flexibility and efficiency, it will also ease the resource strain on collection devices that remain in high demand amid the COVID-19 pandemic. Read more