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11/07/2024

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GE HealthCare raised its revenue and earnings expectations for 2023 as it plans to cut costs.
25/07/2023

GE HealthCare raised its revenue and earnings expectations for 2023 as it plans to cut costs.

The company plans to improve its margins by cutting down on service agreements and by driving more efficiency in manufacturing and supply chain.

J&J raised its full-year earnings forecast for the second quarter in a row, reflecting improved procedure volumes and ne...
20/07/2023

J&J raised its full-year earnings forecast for the second quarter in a row, reflecting improved procedure volumes and new product launches in its medtech segment.

The company raised its revenue and earnings forecast for the year, driven by new products and global procedure growth.

J&J subsidiary Abiomed's heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents,...
19/07/2023

J&J subsidiary Abiomed's heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, according to a recall notice.

There’s a risk that the valve implants can interact with the company’s Impella heart pumps, breaking the motor.

A clinical trial found that overall, treating hearing loss in older adults had no effect on the rate of cognitive declin...
19/07/2023

A clinical trial found that overall, treating hearing loss in older adults had no effect on the rate of cognitive decline over three years. But a smaller analysis showed a big difference in adults who were at increased risk for cognitive decline.

While there were no positive effects observed in healthy older adults, a smaller analysis pointed to a significant difference in those at higher risk of cognitive decline.

Medtronic is recalling nearly 350,000 implantable defibrillators because the devices may deliver a reduced-energy shock,...
18/07/2023

Medtronic is recalling nearly 350,000 implantable defibrillators because the devices may deliver a reduced-energy shock, or no shock at all, when therapy is needed, the FDA said Tuesday.

The implantable defibrillators may fail to deliver an electric shock to restore normal heart rhythm when needed, which could lead to a serious injury or death, the FDA said.

Big Health has bought Limbix to add a treatment for adolescent depression to its portfolio of digital therapeutics.
18/07/2023

Big Health has bought Limbix to add a treatment for adolescent depression to its portfolio of digital therapeutics.

The phone-based treatment, SparkRx, uses self-guided, cognitive behavioral therapy to teach skills such as mood tracking.

ViewRay, a company that makes an MRI-guided radiation therapy system for cancer treatment, filed for Chapter 11 bankrupt...
18/07/2023

ViewRay, a company that makes an MRI-guided radiation therapy system for cancer treatment, filed for Chapter 11 bankruptcy.

The company, which makes an MRI-guided radiation therapy system, intends to sell all or some of its assets.

Responding to concerns about the safety of hernia mesh devices, the FDA analyzed the adverse event reports it has receiv...
17/07/2023

Responding to concerns about the safety of hernia mesh devices, the FDA analyzed the adverse event reports it has received over the past 22 years and reviewed 45 research papers published in the past 11 years.

The FDA’s analysis of adverse event reports describes problems including pain, injury and disability.

QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the FDA. The company received reports that...
17/07/2023

QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the FDA. The company received reports that the tests showed lower than expected troponin levels, and advised clinicians to immediately stop using them.

The company advised clinicians to immediately discontinue using the test and switch to another method if possible.

Becton Dickinson disclosed that it has identified eight cybersecurity vulnerabilities in its Alaris infusion pump system...
14/07/2023

Becton Dickinson disclosed that it has identified eight cybersecurity vulnerabilities in its Alaris infusion pump system.

The company identified eight security issues affecting its infusion pump system, including one high-risk concern.

The FDA approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (B...
14/07/2023

The FDA approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), offering another option to devices made by Teleflex and Boston Scientific.

The company’s Optilume device combines balloon dilation and the delivery of paclitaxel to treat symptoms linked to an enlarged prostate.

The U.S. International Trade Commission (ITC) has delayed a decision on a patent dispute between Apple and Masimo until ...
13/07/2023

The U.S. International Trade Commission (ITC) has delayed a decision on a patent dispute between Apple and Masimo until October.

A potential settlement or royalty payments stemming from Masimo’s claim that Apple’s pulse oximetry features infringed on its patents could offer “significant upside” for Masimo, BTIG analysts wrote.

The FDA has found paclitaxel-coated devices are unlikely to increase the risk of death when used to treat peripheral art...
12/07/2023

The FDA has found paclitaxel-coated devices are unlikely to increase the risk of death when used to treat peripheral arterial disease, leading it to work with device-makers to update labeling.

The FDA’s decision to remove mortality warnings from device labels is a boost to manufacturers of paclitaxel-coated devices.

Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to th...
12/07/2023

Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries.

The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.

Tandem Diabetes Care received FDA clearance for its Mobi insulin pump, a smaller form-factor device that could drive gro...
12/07/2023

Tandem Diabetes Care received FDA clearance for its Mobi insulin pump, a smaller form-factor device that could drive growth for the company next year.

The device, with a much smaller form than Tandem’s past pumps, could drive more people to switch from insulin injections, an analyst with Craig-Hallum said.

The European Commission fined gene sequencing pioneer Illumina about €432 million, the maximum penalty it could impose, ...
12/07/2023

The European Commission fined gene sequencing pioneer Illumina about €432 million, the maximum penalty it could impose, for closing the 2021 acquisition of cancer test developer Grail without first gaining the commission’s approval.

The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.

Researchers and physicians at the University of Pittsburgh and UPMC developed a machine learning model that can identif...
11/07/2023

Researchers and physicians at the University of Pittsburgh and UPMC developed a machine learning model that can identify patients who are at high risk for complications after surgery, according to a study published Friday in JAMA Network Open.

The model outperformed the established calculator of surgical risk and requires less input from clinicians.

CMS is set to propose outpatient reimbursement that will increase sales of Shockwave Medical’s heart disease device, Mor...
11/07/2023

CMS is set to propose outpatient reimbursement that will increase sales of Shockwave Medical’s heart disease device, Morgan Stanley analysts wrote in a note.

The analysts think growth expectations for the company are too low and have set their earnings estimate for next year 15% above Wall Street’s consensus.

Martin Fischer will join Fresenius Medical Care as CFO starting on Oct. 1. Previous CFO Helen Giza was promoted to CEO.
11/07/2023

Martin Fischer will join Fresenius Medical Care as CFO starting on Oct. 1. Previous CFO Helen Giza was promoted to CEO.

Fischer joins the company after former CFO Helen Giza was promoted to CEO.

The election of two new directors to Masimo’s board last month could set the stage for a sale or spinoff of the medtech ...
11/07/2023

The election of two new directors to Masimo’s board last month could set the stage for a sale or spinoff of the medtech company’s Sound United consumer audio division, analysts at Needham said in a report.

Needham analysts say that new voices on the patient-monitoring company’s board, after a proxy battle, could catalyze the sale of the audio unit, even as Masimo pursues its consumer healthcare…

Medtronic received Medicare and Medicare Advantage coverage for its recently approved MiniMed 780G insulin pump.
10/07/2023

Medtronic received Medicare and Medicare Advantage coverage for its recently approved MiniMed 780G insulin pump.

Medtronic has begun processing orders and will start shipping devices over the next few weeks.

Outset Medical disclosed that it received a warning letter last week. The FDA raised concerns with website comments abou...
10/07/2023

Outset Medical disclosed that it received a warning letter last week. The FDA raised concerns with website comments about its Tablo Hemodialysis System, and said that Outset needs clearance for a water filtration device accessory.

The warning letter claims Outset Medical made assertions outside of the current indications for its Tablo dialysis system and needs clearance for a device accessory.

Coloplast has agreed to buy wound care company Kerecis for $1.2 billion upfront.
10/07/2023

Coloplast has agreed to buy wound care company Kerecis for $1.2 billion upfront.

Kerecis’ fish skin biologic, which aids tissue regeneration, helped drive the company’s sales to $74.5 million last year.

ResMed acquired privately held software company Somnoware to gain a web-based platform aimed at sleep labs.
07/07/2023

ResMed acquired privately held software company Somnoware to gain a web-based platform aimed at sleep labs.

The maker of sleep and respiratory care devices said it plans to retain all of Somnoware’s staff and maintain its open platform for patient testing and treatment.

Penumbra CEO Adam Elsesser talked about the company's new products, growth expectations and changes in treatment.
07/07/2023

Penumbra CEO Adam Elsesser talked about the company's new products, growth expectations and changes in treatment.

Penumbra has launched two devices that use computers to control suction of blood clots. That’s helped the company convert some surgeons from traditional methods of clot removal, like open surgery or…

The European Commission is “almost certain” to force Illumina’s divestment of Grail, a move that could happen in the fir...
06/07/2023

The European Commission is “almost certain” to force Illumina’s divestment of Grail, a move that could happen in the first half of 2024, analysts at Canaccord Genuity wrote in a research note.

Canaccord Genuity analysts, commenting on a Financial Times article predicting a record EU fine against the DNA sequencer for closing its Grail acquisition, said it looks “almost certain” regulators…

The successor to ChatGPT delivers answers that agree with health guideline recommendations 60% of the time, but gives lo...
05/07/2023

The successor to ChatGPT delivers answers that agree with health guideline recommendations 60% of the time, but gives low- to moderate-quality information, according to a study published in the Journal of Medical Internet Research.

Researchers recommended limiting the medical information used by GPT-4 to peer-reviewed studies, and adding a bibliography feature to address limitations in the answers provided by the model.

Abbott received FDA approval for a dual-chamber leadless pacemaker system that the company claims is the world’s first.
05/07/2023

Abbott received FDA approval for a dual-chamber leadless pacemaker system that the company claims is the world’s first.

With the new device, Abbott is ramping up competition with Medtronic in the leadless pacemaker market.

Teri Lawver, Dexcom’s chief commercial officer, talked about the company's long-term growth strategy and plans to create...
30/06/2023

Teri Lawver, Dexcom’s chief commercial officer, talked about the company's long-term growth strategy and plans to create a CGM for people with diabetes who don’t take insulin.

The continuous glucose monitor in development for people with Type 2 diabetes who don’t take insulin could expand the CGM market to 25 million more people in the U.S., the company’s new chief…

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